Lawmakers' Aduhelm report throws shade on US medicines regulator

Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab).

Developed by Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523), the biologic was hailed as a once-in-a-generation breakthrough in the treatment of Alzheimer’s disease, when it  gained US Food and Drug Administration approval in June 2021.

However, the initially positive reaction to the Accelerated Approval was muted by accusations of off-the-record discussions between Biogen executives and officials at the FDA, prior to the speedy nod.