In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.

Under fire for approving a questionable drug for all Alzheimer’s patients, the Food and Drug Administration on Thursday greatly narrowed its previous recommendation and is now suggesting that only those with mild memory or thinking problems should receive it. The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million. The approval of Aduhelm early last month was one of the most contentious F.D.A. decisions in years. Groups that represent Alzheimer’s patients had intensely lobbied the agency to sign off on the first new drug to treat the disease in 18 years — and the first ever designed to attack its biological underpinnings.