WASHINGTON - The US Food and Drug Administration on Friday approved a new Alzheimer’s drug that may modestly slow the pace of cognitive decline early in the disease but also carries risks of swelling and bleeding in the brain.
Eisai said the list price for Leqembi would be $26,500 per year. The price is slightly lower than Aduhelm’s but higher than that recommended by some analysts. In its decision, the FDA appeared to be acknowledging the vehement criticism that erupted when it approved Aduhelm in 2021 after both a committee of independent advisers and an FDA council of senior officials said there was not enough evidence that it worked.
The Leqembi label says the drug should be used only for patients in early and mild stages of Alzheimer’s disease, matching the status of patients in the clinical trials of the drug. It instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi attacks.