The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA is set to review Biogen Inc.’s (BIIB) Biologics License Application for Aducanumab on November 6, 2020.Aducanumab is proposed for the treatment of Alzheimer’s disease. Biogen licensed Aducanumab from Neurimmune in 2007. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of Aducanumab globally.In March of 2019, Biogen and Eisai discontinued two phase III trials of Aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia on the recommendation of an Independent data monitoring committee as the trials were unlikely to meet the primary endpoints.However, by October 2019, the companies decided to seek approval of Aducanumab based on a new analysis of a larger dataset from the phase III studies, and a filing in this regard was made early this year. The Biologics License Application for Aducanumab was accepted for priority review by the FDA on August 7, 2020, with the decision date being set for March 7, 2021.Before the FDA reviews Aducanumab, the drug candidate will be scrutinized by a panel of experts on November 6, as mentioned above.If approved, Aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid-beta resulted in better clinical outcomes.If all goes well and Aducanumab gets approved, the drug could achieve peak global sales of about $4.7 billion in 2026, according to GlobalData analyst Alessio Brunello.BIIB closed Friday’s (Oct.23, 2020) trading at $265, down 0.67%.