On 7 August, Biogen and Eisai have announced that the US Food and Drug Administration (FDA) had accepted the biologics license application for aducanumab. The application has been granted priority review and the FDA is now required to make a decision by March 7, 2021. Although the review is already on an accelerated track, the FDA said it would act even earlier if possible. The agency also stated that it is currently planning to hold an Advisory Committee meeting for this application on a yet-to-be-determined date. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease (AD) and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
Nearly one month after completed the submission of its license application for its investigational drug aducanumab, Biogen has received the acceptance of its licence application. The data underpinning the filing came from the phase III EMERGE and ENGAGE studies as well as the Phase Ib PRIME study.