How Did Aduhelm Get the FDA OK?

How did a controversial Alzheimer’s drug pass muster with the FDA without being proven effective?
Meeting minutes reveal that a council of 15 officials concluded that another clinical trial would be needed before greenlighting Biogen’s Aduhelm, or aducanumab.

Such serious doubts had been raised before about the drug’s ability to slow cognitive decline, and studies showing it can cause brain swelling or brain bleeding.
For its part, the FDA has defended its decision process. But the Times details an approval process that took “several unusual turns”—including an unusually close collaboration between Biogen and the FDA.
“To have a virtually unanimous vote against approval and then to have the F.D.A. turn around and approve — that’s never happened,” says former FDA officials Wayne Pines.
The New York Times

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