Eli Lilly &Co.’s drug for Alzheimer’s has benefits that outweigh its risks, U.S. drug regulatory advisers said, bringing the treatment’s long path to the market closer to a successful end. Eleven advisers to the Food and Drug Administration voted unanimously on Monday that Lilly’s donanemab helps patients in the early stages of Alzheimer’s disease, and that those benefits outweight the drug’s risks. The FDA is expected to make a final decision on donanemab by the end of the year. Lilly shares rose 1.8% at the 4 p.m. close of trading in New York.
If approved, donanemab would compete against Leqembi, an Alzheimer’s medicine from Biogen Inc. and Eisai Co. that won U.S. clearance last year. Each targets toxic clumps of a protein called amyloid, which is thought to drive the memory-destroying progression of Alzheimer’s. The intravenous drugs are the first to meaningfully alter the course of the disease in clinical trials, although Leqembi’s commercial uptake has lagged expectations.
Patients who receive amyloid-reducing therapy must first be tested for the presence of the brain protein. Lilly’s study excluded patients with no or low levels of another disease-linked protein, called tau, in their brains, which has raised questions about how widely its drug might be used. “I think the benefits outweigh the risks, and if there are some subgroups where further analysis is required it should not hold up to make this drug available to the public,” Costantino Iadecola, chair of Weill Cornell Medicine’s Feil Family Brain and Mind Research Institute and a panel member, said at the meeting. The FDA has been under fire for its approach to treatments for Alzheimer’s, in part because it still isn’t clear what role amyloid — the protein targeted by drugs like donanemab — plays in the disease.