Biogen's Alzheimer's Drug Aduhelm Review Could Have Been Handled Differently, Says FDA Chief: STAT News

Acting FDA Commissioner Janet Woodcock pushed back against media questions about the agency's controversial approval of Alzheimer's treatment, Aduhelm developed by Biogen Inc BIIB and Eisai Co Ltd ESALY.
During an interview at STAT's Breakthrough Science Summit, STAT journalist Nicholas Florko asked whether she was surprised about the broad label. She replied, "I think we ought to move on."
When Florko then pressed Woodcock if she was aware of a reported meeting between an FDA regulator and Biogen in 2019, Woodcock said she was working for Operation Warp Speed. She then said, "Nick, this is an interrogation right now."
During the interview, Woodcock also acknowledged that the approval process of Biogen's drug could have potentially been handled differently, which could have decreased the controversy.
The FDA's approval of Aduhelm has been in the headlines since last month. The agency had to narrow the label to recommend the use of Aduhelm in mild Alzheimer's patients.
Last week, Woodcock called for a federal investigation into the approval of Aduhelm.
Centers for Medicare & Medicaid Services also started the review process for national Medicare coverage of the drug.
Price Action: BIIB shares are down 5.85% at $331.28, and ESALY shares are down 1.7% at $95.74 during the market session on the last check Thursday.

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