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Published: Jun 28, 2021 By Mark Terry
John Tlumacki/The Boston Globe via Getty Images
The U.S.
approved Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease on June 7, but the fallout continues.
The controversial drug was granted approval despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and assured that the agency was not considering an accelerated approval. But the agency did approve it via an accelerated approval pathway, which used surrogate endpoints, in the case of Aduhelm, removal of amyloid plaques, instead of clinical evidence of improvement in cognition and memory. It also requires post-marketing studies with a nine-year timeline.