Bloomberg Law
Free Newsletter Sign Up
Bloomberg Law
Welcome
Go
Free Newsletter Sign Up

Biogen Alzheimer’s Drug Puts FDA’s Judgment in Harsh Spotlight

Jan. 30, 2021, 1:30 PM

A new drug for Alzheimer’s disease is on a tortuous path toward the U.S. market, and while many patients would hail approval as a major advance, it could also revive concerns about regulators’ scientific integrity.

Biogen Inc. said Friday that the U.S. Food and Drug Administration is extending its review of aducanumab, an experimental therapy that patients and their families see as a potential lifeline. But the agency’s history of cherry-picking effectiveness data on the drug echoes a five-year-old decision to support a treatment for a childhood muscle-wasting disease, one that remains controversial.

FDA watchers and its own staff worry ...