Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.

Human representation resolving a jigsaw puzzle - Image ID: D9T78X

Acting Commissioner Janet Woodcock said the US FDA cleared Biogen, Inc./Eisai Co., Ltd.’s Alzheimer’s drug Aduhelm (aducanumab-avwa) based on “very, very solid” evidence and suggested that concerns about the accelerated approval stemmed from “process problems” during the review.

Speaking to the USA-India Chamber of Commerce’s BioPharma Summit shortly before the release of several of FDA’s review memos for...