{"id":21762,"date":"2020-08-11T12:19:20","date_gmt":"2020-08-11T08:19:20","guid":{"rendered":"https:\/\/www.gncdubai.com\/?p=21762"},"modified":"2026-07-13T22:46:13","modified_gmt":"2026-07-13T18:46:13","slug":"new-alzheimers-drug-could-be-a-game-changer","status":"publish","type":"post","link":"https:\/\/www.gncdubai.com\/ar\/new-alzheimers-drug-could-be-a-game-changer\/","title":{"rendered":"New Alzheimer\u2019s Drug Could Be A \u2018Game Changer\u2019"},"content":{"rendered":"

FDA Accepts Biogen\u2019s Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review.\u00a0<\/em>If approved, aducanumab would be the first treatment<\/em>\u00a0to meaningfully change the course of Alzheimer\u2019s disease<\/em><\/p>\n

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer\u2019s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer\u2019s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.<\/p>\n

\u201cThe FDA\u2019s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer\u2019s disease,\u201d said Michel Vounatsos, Chief Executive Officer at Biogen. \u201cWe look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey. We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer\u2019s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.\u201d<\/p>\n

\u201cReducing clinical decline and maintaining the ability to live an independent life for as long as possible are things that people living with Alzheimer\u2019s disease and their families value in a potential treatment,\u201d said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. \u201cIf aducanumab is approved, we expect that it will make a difference in the lives of people living with Alzheimer\u2019s disease. We believe that this historic milestone is one step towards creating a paradigm shift in treatment for Alzheimer\u2019s disease, a public health issue for aging societies.\u201d<\/p>\n

Biogen did not use its Priority Review voucher for the aducanumab BLA. The FDA also stated that it is currently planning to hold an Advisory Committee meeting for this application on a yet-to-be-determined date.<\/p>\n

\u201cToday, I am heartened by what this progress may mean for people living with Alzheimer\u2019s disease and their families,\u201d said Dr. Christopher van Dyck, M.D., Director of the Yale Alzheimer\u2019s Disease Research Center. \u201cIf aducanumab is determined to be effective in reducing the decline in cognition and activities of daily living resulting from progression of this disease by addressing the underlying disease pathology, it will deliver meaningful benefits to those who most need them.\u201d<\/p>\n

About Aducanumab<\/h2>\n

Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer\u2019s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer\u2019s disease and mild Alzheimer\u2019s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients\u2019 ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer\u2019s.<\/p>\n

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.<\/p>\n

EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer\u2019s Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer\u2019s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).<\/p>\n

About Alzheimer\u2019s Disease<\/h2>\n

Alzheimer\u2019s disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death. The disease currently cannot be stopped, delayed or prevented and is a growing global health crisis, affecting those living with the disease and their families. According to the World Health Organization (WHO), tens of millions of people worldwide live with Alzheimer\u2019s disease, and the number will grow in the years ahead, outpacing the healthcare resources needed to manage it and costing billions of dollars.<\/p>\n

Alzheimer\u2019s disease is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaque, which begins approximately 20 years before patients exhibit symptoms of the disease. Mild cognitive impairment due to Alzheimer\u2019s disease is one of the earliest stages of the disease when symptoms start to be more visible and can be detected and diagnosed. Current research efforts are focused on catching and treating patients as early as possible for the best chance of slowing or stopping the progression of Alzheimer\u2019s disease.<\/p>\n

The full original article was released on GlobeNewswire<\/a><\/p>\n

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FDA Accepts Biogen\u2019s Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review.\u00a0If approved, aducanumab would be the first treatment\u00a0to meaningfully change the course of Alzheimer\u2019s disease CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration<\/p>\n","protected":false},"author":1,"featured_media":21764,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-21762","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"\nNew Alzheimer\u2019s Drug Could Be A \u2018Game Changer\u2019<\/title>\n<meta name=\"description\" content=\"A new Alzheimer's drug has shown significant results in slowing cognitive decline. 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