Enlarge / The Meals and Drug Administration headquarters in White Oak, Maryland. (credit score: Getty | Congressional Quarterly)
Lower than 5 weeks after granting a extremely controversial approval for the Alzheimer’s drug Aduhelm, the Meals and Drug Administration has up to date its suggestion for who ought to obtain the drug. The replace narrows the beneficial affected person pool from all these with Alzheimer’s illness to solely these with gentle types of the illness.
The FDA’s preliminary sweeping suggestion was a extremely contentious side of the drug’s approval, as a result of it wasn’t backed by any information. Aduhelm’s developer, Biogen, had solely included individuals with gentle illness in its scientific trials. The quite a few critics of the approval raised speedy questions as to why the drug can be open to all.
However these critics—together with researchers and trade specialists—aimed most of their ire on the approval itself, provided that Biogen’s scientific trials did not convincingly present that the drug works at treating gentle Alzheimer’s. Actually, Biogen had halted two identically designed Section III trials in 2019 after Aduhelm flunked a “futility evaluation.”
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