Federal health advisers have endorsed a closely watched Alzheimer’s drug from Eli Lilly for people with mild dementia. The FDA will make the final decision on approval later this year. If the agency agrees with its advisers, the drug would only be the second Alzheimer’s drug clearly shown to slow cognitive decline due to Alzheimer’s.
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.
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.
“Imposing a requirement for tau imaging is not necessary and would raise serious practical and access concerns to the treatment,” said Dr. Thomas Montine of Stanford University, who chaired the panel and summarized its opinion. That exclusion prompted FDA reviewers to question whether the drug’s benefits could be generalized to all patients — as suggested by Lilly — or if the drug should be limited to patients like those studied by the company.
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