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6 days ago
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Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Yahoo
6 days ago
- Health
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Yahoo
6 days ago
- Health
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Yahoo
10-06-2025
- Business
- Yahoo
Novo Nordisk to present array of new portfolio data including studies with semaglutide and CagriSema, expanding evidence in obesity and diabetes care at ADA 2025
Full data of Phase 3 REDEFINE 1 and 2 trial results will provide insights on the potential of CagriSema Semaglutide real-world data complements evidence from previous cardiometabolic and kidney outcomes trials Data on pipeline candidate amycretin to underscore Novo Nordisk's scientific efforts to continued innovation in obesity PLAINSBORO, N.J., June 10, 2025 /PRNewswire/ -- Novo Nordisk today announced that new data from its industry-leading cardiometabolic portfolio will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago, June 20 – 23, 2025. A total of 29 abstracts will be presented, including trials investigating the efficacy and safety of CagriSema in people with overweight/obesity (REDEFINE 1) and those with overweight/obesity and type 2 diabetes (REDEFINE 2).1 Further, new data will complement the extensive body of cardiometabolic and kidney evidence for semaglutide in people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from additional real-world studies in adults with obesity.2-4 "We recognize the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalized treatment approach," said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. "As we look to build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease." The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's scientific efforts to deliver innovation in cardiometabolic diseases and individualized healthcare solutions.1 On June 22nd, Novo Nordisk will also host an R&D investor event on our metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. Full details of Novo Nordisk abstracts to be presented at ADA 2025. These data for medicines containing semaglutide, CagriSema, amycretin, insulin icodec, and IcoSema are investigational: ADA Scientific Sessions:
Yahoo
10-06-2025
- Health
- Yahoo
ADA 2025: Novo Nordisk highlights strong portfolio data with new semaglutide and CagriSema results, redefining possibilities in obesity and diabetes care
Novo Nordisk to present data from STEP UP trial on a higher dose of Wegovy® (semaglutide 7.2 mg) for those in need of greater weight loss Data will expand semaglutide evidence in both a clinical and real-world setting, including cardiometabolic and kidney health benefits for those with obesity and diabetes Novo Nordisk continues to pioneer obesity innovation, including presentation of full Phase 3 REDEFINE 1 and 2 trial results, providing insights into the transformational potential of CagriSema Bagsværd, Denmark, 10 June – Novo Nordisk today announced that new data from its industry-leading portfolio in metabolic and cardiovascular health will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 – 23 June 2025. A total of 29 abstracts will be presented, including trials investigating the weight loss efficacy of higher dose Wegovy® (semaglutide 7.2 mg) in people with obesity (STEP UP) and those with obesity and type 2 diabetes (STEP UP T2D) as a new option for those in need of greater weight loss. New data will offer additional evidence of the broader cardiovascular and kidney health benefits of semaglutide for people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from further real-world studies of semaglutide 2.4 mg. The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the transformational potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's commitment to obesity innovation and individualised healthcare solutions. On 22 June, Novo Nordisk will also host an R&D investor event on their metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. 'Aiming to address individual needs and preferences for better health, we look forward to providing a higher dose of Wegovy® (semaglutide 7.2 mg) for people with obesity in need of more significant weight loss, alongside the broader health benefits seen with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'Semaglutide has shown comprehensive and disease-modifying effects across the metabolic and cardiovascular health spectrum, and the data presented at ADA 2025 for Wegovy®, Rybelsus®, and Ozempic® will add to this evidence base as we aspire to a future where semaglutide is a foundational therapy that can provide people with comprehensive protection, early enough to make a difference.' 'We recognise the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalised treatment approach,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'As we look to further build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease.' Novo Nordisk data overview at ADA 2025: ADA Scientific Sessions: Diabetes and peripheral artery disease—evolving role of GLP-1 RA and new insights from the STRIDE trial - Saturday 21 June; 13:30–15:00 CDT Efficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 clinical trials - Sunday 22 June; 8:00–9:30 CDT SOUL trial—effects of oral semaglutide on cardiovascular (and other) outcomes in people with type 2 diabetes at high CV risk - Sunday 22 June; 16:30–18:00 CDT Novo Nordisk poster and oral presentations: Ozempic® (once-weekly semaglutide 1.0 mg) Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD: data from the FLOW Trial. Poster presentation (1971-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: a long-term cost effectiveness analysis based on FLOW. Poster presentation (782-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures in US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) who received once-weekly (OW) semaglutide. Poster presentation (838-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures among US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) receiving once-weekly semaglutide (sema OW) vs. oral antidiabetic medications (ADMs). Poster presentation (2005-LB poster) - Sunday 22 June; 12:30–13:30 CDT Effect of type 2 diabetes characteristics on semaglutide treatment in people with type 2 diabetes and peripheral artery disease: a post-hoc analysis of the STRIDE Trial. Oral presentation (291-OR) - Monday 23 June; 13:30–13:45 CDT Rybelsus® (once-daily oral semaglutide) Real-world impact of oral semaglutide (sema) alone and vs DPP-4is on weight, BMI and HbA1c outcomes in type 2 diabetes (T2D): an observational study (PAUSE). Poster presentation (732-P) - Sunday 22 June; 12:30–13:30 CDT Oral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (292-OR) - Monday 23 June; 13:45–14:00 CDT Wegovy® (once-weekly semaglutide 2.4 mg) Demographic and clinical characteristics associated with real-world persistence on semaglutide for weight management in the USA. Poster presentation (786-P) - Sunday 22 June; 12:30–13:30 CDT Two-year real-world effectiveness of semaglutide in patients with obesity or overweight. Poster presentation (1733-P) - Monday 23 June; 12:30–13:30 CDT Reduction of the 10-Year ASCVD risk in patients with overweight or obesity treated with semaglutide 2.4 mg in routine clinical care: a real-world study. Poster presentation (1734-P) - Monday 23 June; 12:30–13:30 CDT Once-weekly semaglutide 7.2 mg Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB ePoster) - Saturday 21 June; 13:30–15:00 CDT Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB poster) - Sunday 22 June; 12:30–13:30 CDT Efficacy and safety of semaglutide 7.2 mg in obesity and type 2 diabetes: STEP UP T2D trial. Poster presentation (1978-LB poster) - Sunday 22 June; 12:30–13:30 CDT CagriSema Effect of combined therapy with once-weekly subcutaneous cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) on energy intake, gastric emptying, and appetite in adults with overweight or obesity. Poster presentation (1969-LB poster) - Sunday 22 June; 12:30–13:30 CDT Diabetes, cagrisema-induced weight loss in diet-induced obese rats relies on preserved mitochondrial leak respiration in skeletal muscle. Poster presentation (1693-P) - Monday 23 June; 12:30–13:30 CDT Amycretin/amylin The amylin receptor selective agonist NN1213 reduces food intake and body weight in rats without decreasing calcium plasma levels. Oral presentation (86-OR) - Friday 20 June; 14:45–15:00 CDT Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Poster presentation (2002-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly insulin icodec Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by diabetes duration: ONWARDS 1–5. Poster presentation (816-P) - Saturday 21 June; 12:30– 13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline A1C: ONWARDS 1–5. Poster presentation (822-P) - Saturday 21 June; 12:30–13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline BMI: ONWARDS 1–5. Poster presentation (819-P) - Saturday 21 June; 12:30–13:30 CDT Once-weekly IcoSema CGM-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3. Poster presentation (815-P) - Saturday 21 June; 12:30–13:30 CDT A1C and hypoglycemia outcomes with once-weekly IcoSema vs comparators in T2D by kidney function. Poster presentation (804-P) - Saturday 21 June; 12:30–13:30 CDT CGM-based outcomes in adults with T2D receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3. Poster presentation (830-P) - Saturday 21 June; 12:30–13:30 CDT Comparison of characteristics among individuals with established vs newly diagnosed type 2 diabetes during ischemic stroke hospitalization – a retrospective cohort study. Poster presentation (1373-P) - Saturday 21 June; 12:30–13:30 CDT Digital Health Effect of telemonitoring using connected devices on insulin injection adherence in people living with T2D. Oral presentation (315-OR) - Monday 23 June; 13:30–13:45 CDT Tracking treatment outcomes using the semaglutide patient support solution app. Poster presentation (1098-P) - Sunday 22 June; 12:30–13:30 CDT General diabetes Prevalence and factors for treatment failure with sodium-glucose co-transporter 2 inhibitor (SGLT2i) in US adults with type 2 diabetes (T2D). Poster presentation (909-P) - Sunday 22 June; 12:30–13:30 CDT Macrovascular and microvascular complications in Medicare patients with type 2 diabetes and atherosclerotic cardiovascular disease from 2006-2021: incidence stratified by sex, age, and race/ethnicity. Poster presentation (1870-LB poster) - Sunday 22 June; 12:30–13:30 CDT Elevated body mass index at type 2 diabetes diagnosis is associated with increased risk of cardiovascular disease and kidney outcomes. Poster presentation (427-P) - Monday 23 June; 12:30–13:30 CDT General obesity Health utilities of people with obesity in Taiwan: a nationwide representative analysis. Publication Only (63-PUB) About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018.1 Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness, thereby helping people eat less and reduce their calorie intake. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration. About once-weekly basal insulin icodec Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. About once-weekly IcoSema Once-weekly IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin icodec/1mg semaglutide). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ 1 Novo Nordisk data on file. Attachment PR250610-ADA-Curtain-RaiserSign in to access your portfolio
