The panel of experts between Biogen and billions
Biogen’s decision to seek approval for a once-terminated treatment for Alzheimer’s disease is going to put a lot of pressure on the FDA. But before the agency gets to make its final decision, Biogen will have to win over a roundtable of experts in the Maryland suburbs.
That roundtable is called an advisory committee, and it’s tasked with voting on whether the FDA should approve a given product. The votes are non-binding, but when there’s controversy involved — and there’s plenty when it comes to Biogen’s drug — those panel decisions can be key indicators of where the FDA is headed.
STAT talked to experts with experience at the FDA’s neurology panel, the one that governs Alzheimer’s drugs, and they had some ominous warnings for Biogen. The company’s data merits a rejection on its face, according to one neurologist. And the very fact the FDA is convening a panel suggests the agency is looking for a reason to say no, according to another.
Read more.
That roundtable is called an advisory committee, and it’s tasked with voting on whether the FDA should approve a given product. The votes are non-binding, but when there’s controversy involved — and there’s plenty when it comes to Biogen’s drug — those panel decisions can be key indicators of where the FDA is headed.
STAT talked to experts with experience at the FDA’s neurology panel, the one that governs Alzheimer’s drugs, and they had some ominous warnings for Biogen. The company’s data merits a rejection on its face, according to one neurologist. And the very fact the FDA is convening a panel suggests the agency is looking for a reason to say no, according to another.
Read more.
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