Biogen application for Alzheimer's drug accepted in Europe

• The European Medicines Agency (EMA) accepts for review Biogen's (NASDAQ:BIIB) marketing application for aducanumab for the treatment of patients with mild cognitive impairment due to Alzheimer's disease (AD).
• The company's U.S. application is currently under FDA review with an action date of March 7, 2021.
• If approved, it will be the first authorized medicine to reduce the clinical decline of AD and the first to show that removing amyloid beta resulted in improved clinical outcomes.
• The company has a lot riding on a nod in either or both jurisdictions since it has an acute need for a growth driver. The company is optimistic about approval based on the totality of the data. Results from two Phase 3 studies were uneven however. In the EMERGE trial. the high-dose arm met the primary and two secondary endpoints at week 78 but the low-dose arm missed all endpoints. In the ENGAGE study, both the high-dose and low-dose arms failed to achieve the primary or secondary endpoints.
• https://seekingalpha.com/news/3628974-biogen-application-for-alzheimers-drug-accepted-in-europe