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Patient Support May Have Helped Push Aduhelm Toward Approval

 
• By Derrick Gingery

After largely negative advisory committee meeting, a patient group held a listening session with the FDA to be sure their voices were heard during the review of Biogen's aducanumab.

Alzheimer's brain scan and drugs
Aduhelm's approval could help drive clinical development of other Alzheimer's disease treatments. • Source: Alamy

After the US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee largely voted against Biogen, Inc.’s Alzheimer’s disease treatment Aduhelm (aducanumab) in November 2020, the Alzheimer’s Association took action, apparently to combat the negative sentiment.

The group scheduled a listening session with Patrizia Cavazzoni, then the acting director of the FDA’s Center for Drug Evaluation and Research. The Alzheimer’s Association already had expressed its support...

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