In October 2019, Biogen and Eisai announced plans to pursue regulatory approval for aducanumab, a monoclonal antibody drug that targets aggregated amyloid-beta proteins in Alzheimer’s disease. On 7 August, the US Food and Drug Administration (FDA) accepted the biologics licence application for aducanumab for priority review. If approved, aducanumab would become the first disease-modifying therapy for Alzheimer’s disease (AD).
On 2 October this year, the FDA announced that aducanumab would be discussed at an upcoming meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, to be held on 6 November. The meeting will be broadcast live online, via the FDA website. By November 4, the FDA will share all background material and prerecorded presentations online. Interested parties can also submit questions, information or data, which will be considered by the FDA and, if submitted prior to October 23, forwarded to the committee.
