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The drug, Leqembi, may modestly slow cognitive decline in early stages of the disease but carries some safety risks. Still, data suggests it is more promising than the small number of other available treatments.
The drug, lecanemab, made by Eisai and Biogen, also carried risks of brain swelling and bleeding and should be studied further, a report of the findings said.
The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and uncertain evidence that it helps patients.
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
