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And Then There Were Three: Woodcock Offers Another Explanation For Aduhelm’s Labeling Fiasco

 
• By Sarah Karlin-Smith

Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.

broad horizon
Woodcock said it is standard policy for the Office of Neuroscience to issue broad labels. • Source: Alamy

The US Food and Drug Administration’s Office of Neuroscience “was following its established policies for neurodegenerative diseases,” when it granted Biogen, Inc.’s Alzheimer’s drug Aduhelm (aduncaumab-avwa) an initially broad label, Acting Commissioner Janet Woodcock said.

When they find an effective treatment, the office typically does not narrow the label to one stage of a disease but writes a broader indication, Woodcock

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