Posted by Michael Wonder on 22 Jun 2021
FDA approved Biogen Alzheimer’s drug despite some staff concerns
22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works.
The U.S. FDA approved the first new Alzheimer’s drug in decades over the objection of agency statisticians who said there was insufficient evidence to support approval, according to newly released internal memos.
In the internal memos released Tuesday, FDA officials discussed whether to approve the drug from Biogen over objections from the agency’s drug statistics office, which said that clinical trial data fell short of the proof typically required to put a new product on the market.
Ultimately, top officials decided that the evidence indicating that the drug worked, while inconclusive, was strong enough to allow doctors and patients to decide for themselves whether to take it, according to the memos.
