WASHINGTON — A closely watched Alzheimer's drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment's expected approval for people with mild dementia caused by the brain-robbing disease. A panel of Food and Drug Administration advisers voted unanimously that the drug's ability to modestly slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored. “I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann, a statistician from the National Institutes of Health.
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.
to convincingly slow cognitive decline and memory problems due to Alzheimer's. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year. In a separate vote, the FDA advisers voted unanimously that the Lilly drug was shown effective in various subgroups of patients.
Lilly studied its drug by grouping patients based on their levels of a brain protein, called tau, that predicts severity of cognitive problems. That prompted FDA reviewers to question whether patients should be screened via brain scans for tau before getting the drug. But most panelists thought there was enough evidence of the drug's bene.