Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals
Acting FDA commissioner Janet Woodcock publicly defended Biogen’s controversial Alzheimer’s drug Aduhelm on Tuesday, saying it’s “a very solid” accelerated approval, and “has a lot more supportive data” than many other drugs that have won accelerated approval over the years.
While Woodcock did not delve into which past accelerated approvals had less supportive data than Aduhelm, she did acknowledge some “process problems” with the Aduhelm approval, noting that the advisory committee did not vote against Aduhelm being approved under the accelerated pathway. But she stopped short of mentioning that the committee was never asked to consider an accelerated approval, and multiple FDA officials assured the adcomm panelists that an accelerated approval wasn’t in the cards.
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