FDA Walks Back Approval of Controversial Alzheimer’s Drug
A few weeks ago we wrote about the FDA’s approval of Aduhelm for the treatment of Alzheimers’. It was the first new drug approved for treatment of the disease in decades, but it’s efficacy was greatly disputed even then. Now after weeks of controversy, the FDA has partially walked back the approval, ruling that it should only be prescribed to people with a mild version of the neurodegenerative disease. From Ars Technica.
“The FDA’s initial sweeping recommendation was a highly contentious aspect of the drug’s approval, because it wasn’t backed by any data. Aduhelm’s developer, Biogen, had only included people with mild disease in its clinical trials. The numerous critics of the approval raised immediate questions as to why the drug would be open to all.
But those critics—including researchers and industry experts—aimed most of their ire at the approval itself, given that Biogen’s clinical trials failed to convincingly show that the drug works at treating mild Alzheimer’s. In fact, Biogen had halted two identically designed Phase III trials in 2019 after Aduhelm flunked a “futility analysis.”
Now, the acting head of the FDA is calling for an independent investigation of Aduhelm’s approval, to determine if the approval process was “inconsistent with FDA policies and procedures.” At this time the drug is still on the market, and there are no announced plans to pull it.
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