European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease
- If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrate that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease.
“Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application.”
“There are no treatments available that impact the progression of Alzheimer’s disease by addressing the underlying disease pathology. The potential that aducanumab may hold to effectively reduce the clinical decline brings new hope to people and families living with this devastating disease,” said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “The acceptance of the Marketing Authorization Application in the European Union is an important milestone as we work towards making this potential treatment available around the world.”
Aducanumab is also under review with the U.S. Food and Drug Administration with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021.
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ 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’s.