Alzheimer’s drug that can slow disease gets backing from FDA advisers

FILE – A sign for Eli Lilly & Co. sits outside their corporate headquarters in Indianapolis on April 26, 2017. A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, June 10, 2024, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease.

The FDA will make the final decision on approval later this year. If the agency agrees with the panel’s recommendation, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the U.S. shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug,

The FDA had been widely expected to approve the drug in March. But instead the agency said it would ask its panel of neurology experts to publicly review the company’s data, anAt a high level, Lilly’s results mirrored those of Leqembi, with both medications showing a modest slowing of cognitive problems in patients with early-stage Alzheimer’s.

The main safety issue with donanemab was brain swelling and bleeding, a problem common to all amyloid-targeting drugs.

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