Latest news with #Ozempic®
Yahoo
23-06-2025
- 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
23-06-2025
- 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
23-06-2025
- 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
04-06-2025
- Business
- Yahoo
In National Advertising Division Challenge, Bayview Pharmacy Voluntarily Discontinues Claims for its Compounded Semaglutide
BBB National Programs' National Advertising Division reviewed a challenge brought by Novo Nordisk Inc. regarding express and implied advertising claims made by Bayview Pharmacy Inc. for its compounded semaglutide products. New York, NY, June 04, 2025 (GLOBE NEWSWIRE) -- BBB National Programs' National Advertising Division reviewed a challenge brought by Novo Nordisk Inc. regarding express and implied advertising claims made by Bayview Pharmacy Inc. for its compounded semaglutide products. Novo Nordisk is a global pharmaceutical company specializing in diabetes care, including insulin and related products, as well as other chronic conditions including obesity, rare diseases, and cardiovascular conditions. Novo Nordisk is the sole manufacturer of the only FDA-approved semaglutide medicines: Ozempic® and Wegovy®. Bayview, a compounding pharmacy, marketed five concentrations of compounded semaglutide product for sublingual application for blood-sugar control and weight loss on its website. Novo Nordisk argued that Bayview's advertising conveyed misleading messages, including that its compounded 'semaglutide' sublingual suspensions are Ozempic® and/or is the same as a generic version of Ozempic®. In addition, Novo Nordisk argued that Bayview makes several misleading superiority claims about the bioavailability of its compounded semaglutide sublingual suspension. During the inquiry, Bayview informed the National Advertising Division (NAD) that it had permanently discontinued the challenged claims. Therefore, NAD did not review the claims on their merits and will treat the discontinued claims, for compliance purposes, as though NAD recommended they be discontinued. In its advertiser statement, Bayview stated it 'will comply with NAD's recommendations' and that it 'appreciates NAD's guidance.' All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. Per NAD/NARB Procedures, this release may not be used for promotional purposes. About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than 20 globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create fair competition for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and create fair competition for business. CONTACT: Name: Jennie Rosenberg Email: jrosenberg@ Job Title: Media RelationsSign in to access your portfolio
Malaysian Reserve
26-04-2025
- Business
- Malaysian Reserve
Novo Nordisk protects US patients with legal wins against compounders, including ruling that permanently prohibits compounding pharmacy from selling illegitimate, knockoff Wegovy® or Ozempic®
Federal court ruling leaves in place FDA's decision resolving the shortage of Wegovy® and Ozempic®, which are fully available nationwide, and ends the grace period for pharmacies to make or sell compounded 'versions' of these medicines Separate federal court ruling permanently bars MediOak Pharmacy LLC from marketing or selling illegitimate 'semaglutide' drugs Legal wins build on 111 lawsuits filed by Novo Nordisk across 32 states against entities unlawfully marketing and selling compounded 'semaglutide' drugs, helping safeguard Americans from knockoffs made with unsafe or illicit foreign API Novo Nordisk is dedicated to dialogue with companies to support patient access to authentic, FDA-approved Wegovy® under the care of a licensed healthcare professional PLAINSBORO, N.J., April 25, 2025 /PRNewswire/ — Yesterday, a Texas federal court ruled in favor of Novo Nordisk and FDA, denying a compounding trade association's motion to freeze the FDA's decision to end the shortage of semaglutide injectable medicines. The court's ruling left in place FDA's prior determination that all doses of Wegovy® and Ozempic® are fully available nationwide and that Novo Nordisk's supply of these FDA-approved medicines is meeting or exceeding current and projected nationwide patient demand. With the FDA's resolution of the shortage of Ozempic® and Wegovy®, as left in place by this court ruling, it is illegal under US compounding laws to make or sell knockoff 'semaglutide drugs,' with rare exceptions. In light of the court's decision today, FDA may immediately take action against 503A pharmacies compounding knockoff versions of Novo Nordisk's FDA-approved semaglutide medicines. The ruling also means the grace period for 503B outsourcing facilities to compound semaglutide injectable drugs will expire on May 22, 2025, and FDA may take enforcement action against these entities after that date. This latest win on behalf of patients follows another key decision by the District Court for the Southern District of Texas, where a federal judge entered a final judgment and permanent injunction in favor of Novo Nordisk, against a 503A pharmacy, MediOak Pharmacy LLC, permanently prohibiting them from marketing or selling compounded 'semaglutide' knockoff drugs. 'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy® and Ozempic® is resolved,' said Steve Benz, Corporate Vice President, Legal and US General Counsel, Novo Nordisk. 'FDA's determination was based on a thorough review of Novo Nordisk's stable and growing supply of these important FDA-approved medicines. With the end of the shortage of Wegovy® and Ozempic®, no patient should have to be exposed to unsafe, inauthentic 'semaglutide' drugs. Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate 'semaglutide' drugs are working. We will continue driving these actions forward and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.' Illicit foreign API in compounded 'semaglutide' The resolution of the semaglutide injection shortage and the court's ruling also help protect patients against the proliferation of unsafe and unlawful drugs compounded using imports of synthetic 'semaglutide' active pharmaceutical ingredients (APIs) that are manufactured overseas. A recently published Brookings Institute report titled The Wild East of semaglutide confirms that many US patients are being exposed to unsafe and illegal imports of synthetic semaglutide APIs from China. The report highlights numerous issues, including that manufacturers of chemically synthesized semaglutide API have no external reference standard for quality and instead determine specifications themselves. It also demonstrated that three Chinese firms are responsible for 20% of the reported quantity of semaglutide imported into the US between March 2023 and September 2024 and have never been inspected by FDA, as of September 2024. Additionally, another three Chinese firms, responsible for nearly 45% of reported imported volume during this 18-month period, were cited during their latest FDA inspection for current good manufacturing practice violations. As this report shows, the quality of API originating from China and used in compounded 'semaglutide' in the US cannot be assured and puts patients at serious risk. Novo Nordisk does not directly or indirectly distribute the semaglutide API in its FDA-approved medicines to any entity for use in compounding. Novo Nordisk federal lawsuits filed to date To date, the company has filed 111 lawsuits in federal courts across 32 states against entities unlawfully marketing and selling compounded 'semaglutide,' including drugs that pose significant risks to patient safety due to high levels of impurities (as high as 33%) or misbranded due to inaccurately labeled strengths. Many of these courts have already issued injunctions permanently prohibiting these entities from the unlawful marketing and sales of compounded drugs: Earlier this year, a federal court in Delaware entered an $8.5 million default judgment in Novo Nordisk's favor against a business for willfully and falsely claiming that their compounded 'semaglutide' drugs were equivalent to Ozempic® or used the same active ingredient as FDA-approved Ozempic®. Another federal court permanently prohibited a compounding pharmacy in Tennessee, Midtown Express, from marketing or selling knockoff 'semaglutide' after Novo Nordisk sued it for selling a drug that contained no semaglutide at all. In another case, a federal court granted a default judgement against an online marketer sued by Novo Nordisk, ending its unlawful practice of selling compounded 'semaglutide' directly to consumers without a prescription or instructions for use, misleadingly labeling it as for 'Research Use Only.' Dozens of other courts have entered permanent injunctions against the entities sued by Novo Nordisk, permanently forbidding them from falsely claiming that knockoff 'semaglutide' drugs: (1) are genuine Novo Nordisk medicines; (2) are approved by FDA, are authentic generic medicines, or are safe and effective; (3) achieve any therapeutic result or are safe or effective based on the clinical trial results for Novo Nordisk's approved medicines; and (4) contain semaglutide that has been approved by FDA, is supplied by Novo Nordisk, or is the same as that in Wegovy® and Ozempic®. The court orders also direct businesses to correct misimpressions among patients that were caused by the defendants' deceptive practices. This includes posting prominent disclosures in marketing and advertising to make clear that the unapproved compounded drugs have not been reviewed or approved by the FDA, that the manufacturing processes used to make the drugs are not FDA-reviewed, and that actual FDA-approved semaglutide medicines are available. Actions taken by third parties to warn the public Novo Nordisk supports the actions that have already been taken by law enforcement to protect patients from illegal marketing and sales of compounded drugs. A bipartisan coalition of 38 state Attorneys General have called on the FDA to take swift action against compounding pharmacies that 'cut corners in pursuit of a quick profit' and sell knockoff drugs that could lead to 'serious public health issues.' The Ohio Attorney General recently issued a press release about letters it sent to 14 entities warning them to stop deceiving patients into believing that compounded drugs are approved by the FDA or have been reviewed for safety, effectiveness, or quality and declaring that patients 'deserve clear and accurate information about the medication they're putting in their bodies.' Similarly, in December 2024, the Illinois Attorney General issued cease-and-desist letters to five Chicagoland med spas advertising name brand medications like Wegovy® and Ozempic® but 'instead offering unapproved versions of these products that may put people's health at risk.' In addition, over a dozen Attorneys General have issued statements discussing the dangers posed by knockoff 'semaglutide,' including North Carolina, South Carolina, and Tennessee. The Federal Bureau of Investigation also recently warned the public about safety concerns related to fraudulent compounding practices associated with weight loss drugs, warning that '[s]ome healthcare providers are using compounded mixtures of unknown drugs that do not contain semaglutide, drugs with high levels of impurities, and unsafe or unapproved drugs.' Novo Nordisk is continuing to actively address this issue through education, advocacy, and legal action, fighting on behalf of patients who deserve to know what they are injecting into their body. For more information about Novo Nordisk's efforts to protect patients and ensure access to safe, effective FDA-approved treatments, visit About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at
