Latest news with #PriyaSinghal
Toronto Star
4 days ago
- Health
- Toronto Star
ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the first treatment authorized within the European Union specifically indicated to treat depressive symptoms for women with PPD. ZURZUVAE is a once-daily, oral, 14-day treatment which was approved by the U.S. Food and Drug Administration (FDA) in 2023. 'This is an important milestone for maternal health in the European Union,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'ZURZUVAE represents a novel therapeutic approach for the targeted treatment of postpartum depression, with data demonstrating potential for symptom improvement as early as day three of a 14-day course. If approved, this represents a significant opportunity to advance the treatment of a serious condition that remains both underdiagnosed and undertreated.'
Yahoo
4 days ago
- Health
- Yahoo
ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the first treatment authorized within the European Union specifically indicated to treat depressive symptoms for women with PPD. ZURZUVAE is a once-daily, oral, 14-day treatment which was approved by the U.S. Food and Drug Administration (FDA) in 2023. 'This is an important milestone for maternal health in the European Union,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'ZURZUVAE represents a novel therapeutic approach for the targeted treatment of postpartum depression, with data demonstrating potential for symptom improvement as early as day three of a 14-day course. If approved, this represents a significant opportunity to advance the treatment of a serious condition that remains both underdiagnosed and undertreated.' PPD is one of the most common medical conditions associated with pregnancy.1-3 Symptoms of PPD may include depressed mood, anxiety, affected ability to bond with the newborn, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.1 Left untreated, PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidities and repercussions on child development.4-6 In Europe, an estimated 5-20% of women with a pregnancy experience symptoms of PPD.7-12 Because clinical guidelines for screening and management of depression during and after pregnancy vary across European countries, many cases may go undiagnosed and untreated.3 Death by suicide during the perinatal period is a leading cause of maternal mortality in Europe.4, 13 The CHMP's recommendation for ZURZUVAE is based on the SKYLARK Study evaluating ZURZUVAE which met its primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo. All key secondary endpoints were also met, with significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45 compared to placebo. ZURZUVAE was generally well-tolerated. The most frequently reported side effects ≥ 5% and greater than placebo in patients treated with ZURZUVAE 50 mg were somnolence, dizziness, and sedation. The CHMP's recommendation for ZURZUVAE will now be reviewed by the EC for marketing authorization in the European Union with a final decision expected in the third quarter of 2025. The U.S. FDA approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance on October 31, 2023. About ZURZUVAE® (zuranolone)In the U.S., ZURZUVAE® is a once-daily, oral, 14-day medicine for treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. ZURZUVAE was discovered by Sage Therapeutics, Inc. (Nasdaq: SAGE), and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including relating to; the potential, benefits, safety and efficacy of zuranolone (marketed under the brand name ZURZUVAE); the potential of Biogen's commercial business and pipeline programs, including ZURZUVAE; the anticipated benefits and potential of Biogen's collaboration arrangement with Sage; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References: American Psychiatric Association, Diagnostic and statistical manual of mental disorders (5th ed.). 5 ed. 2013, Washington, DC. Vigod, S.N., et al., Canadian Network for Mood and Anxiety Treatments 2024 Clinical Practice Guideline for the Management of Perinatal Mood, Anxiety, and Related Disorders: Guide de pratique 2024 du Canadian Network for Mood and Anxiety Treatments pour le traitement des troubles de l'humeur, des troubles anxieux et des troubles connexes perinatals. Can J Psychiatry, 2025: p. 7067437241303031. Motrico, E., et al., Clinical practice guidelines with recommendations for peripartum depression: A European systematic review. Acta Psychiatr Scand, 2022. 146(4): p. 325-339. The Lancet Regional, H.-E., Support not stigma: redefining perinatal mental health care. Lancet Reg Health Eur, 2024. 40: p. 100930. Slomian, J., et al., Consequences of maternal postpartum depression: A systematic review of maternal and infant outcomes. Womens Health (Lond), 2019. 15: p. 1745506519844044. Rogers, A., et al., Association Between Maternal Perinatal Depression and Anxiety and Child and Adolescent Development: A Meta-analysis. JAMA Pediatr, 2020. 174(11): p. 1082-1092. Clavenna, A., et al., Postnatal depression screening in a paediatric primary care setting in Italy. BMC Psychiatry, 2017. 17(1): p. 42. Cena, L., et al., Prevalence of maternal antenatal and postnatal depression and their association with sociodemographic and socioeconomic factors: A multicentre study in Italy. J Affect Disord, 2021. 279: p. 217-221. Della Corte, L., et al., Prevalence and associated psychological risk factors of postpartum depression: a cross-sectional study. J Obstet Gynaecol, 2022. 42(5): p. 976-980. Pataky, E.A. and U. Ehlert, Longitudinal assessment of symptoms of postpartum mood disorder in women with and without a history of depression. Arch Womens Ment Health, 2020. 23(3): p. 391-399. Dekel, S., et al., The dynamic course of peripartum depression across pregnancy and childbirth. J Psychiatr Res, 2019. 113: p. 72-78. Holm, D.L., et al., A quantitative comparison of two measures of postpartum depression. BMC Psychiatry, 2022. 22(1): p. 202. Diguisto, C., et al., Maternal mortality in eight European countries with enhanced surveillance systems: descriptive population based study. BMJ, 2022. 379: p. e070621. MEDIA CONTACT:Allison Murphy+ 1 781 464 INVESTOR CONTACT:Tim Power+1 781 464 2442IR@
Hamilton Spectator
22-07-2025
- Health
- Hamilton Spectator
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. 'At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.' Key Scientific Sessions and Presentations: Educational Program on Tau in Alzheimer's Disease At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer's disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on , building on the resources already available. For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth. About BIIB080 BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis. About LEQEMBI ® (lecanemab) LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at . Follow us on social media - Facebook , LinkedIn , X , YouTube . Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Business Upturn
22-07-2025
- Business
- Business Upturn
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. 'At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.' Key Scientific Sessions and Presentations: Lecanemab Clarity AD OLE in Early AD: Initial Findings from 48-Month Analysis Wednesday, July 30, 8:00–8:45 AM ET Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease Wednesday, July 30, 9:00–10:30 AM ET Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery Sunday, July 27, 8:00–8:45 AM ET Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway Learnings Sunday, July 27, 9:00–10:30 AM ET Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported Results Sunday, July 27, 4:14–5:45 PM ET Innovations in Tau Therapies and Biomarkers for Alzheimer's Disease: Bridging Research and Clinical Practice Wednesday, July 30, 2:00–3:30 PM ET Baseline Characteristics from CELIA: A Phase 2 Study to Evaluate BIIB080 in Participants with Early Alzheimer's Disease Monday, July 28, 7:30 AM–4:15 PM ET Educational Program on Tau in Alzheimer's Disease At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer's disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on building on the resources already available. For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth. About BIIB080 BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis. About LEQEMBI ® (lecanemab) LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media – Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Reuters
16-04-2025
- Health
- Reuters
EU authorizes Eisai-Biogen's drug for early Alzheimer's treatment
April 15 (Reuters) - The European Commission on Tuesday authorized the use of Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than two-year-long review process. This makes Leqembi the first approved drug in the European Union that targets an underlying cause of the fatal mind-wasting disease. It had been under regulatory review since January 2023. here. Biogen's head of development, Priya Singhal, said the company and its partner Eisai were "moving with urgency" to make the therapy available to patients in Europe. Rival Eli Lilly's (LLY.N), opens new tab Alzheimer's drug was rejected last month as its benefits were not significant enough to outweigh serious safety risks. The authorization allows the use of Leqembi to treat people with only one or no copy of the ApoE4 gene and who exhibit sticky clumps of a protein called amyloid beta in the brain, which is believed to be a hallmark of Alzheimer's. The decision to exclude those with two copies of the gene is the regulator leaning on the side of safety, said William Blair analyst Myles Minter. He estimates over $900 million peak sales for the drug in the 2030s. The EC's decision is in line with that of the European Medicines Agency, which recently reiterated that Leqembi would be approved for a narrower set of patients than those in which it was tested. The regulator had backed Leqembi for patients with only one copy of the ApoE4 gene, but the EC had requested another safety review. Initially, the European medicines regulator had refused to back the drug's approval due to serious safety risks. Leqembi is approved in the United States for patients with two copies of the gene, but patients must undergo regular brain scans to monitor for any brain swelling. Leqembi is also approved in Japan, China, Great Britain and several other markets.
