FDA Panel Unanimously Supports Eli Lilly’s Alzheimer’s Drug Donanemab

An independent panel advised the FDA to approve Eli Lilly's Donanemab, an experimental drug for early Alzheimer's disease. The panel's positive vote, following a unique trial differing from Eisai and Biogen’s method, suggests significant benefits. The FDA's decision is pending, although it typically follows such recommendations.

Outside advisers to the U.S. Food and Drug Administration on Monday unanimously voted that data for Eli Lilly's experimental Alzheimer's drug, donanemab, showed that it was effective in patients with early Alzheimer's disease, ahead of the agency's decision on approving the drug. The panel discussion focused on some unique aspects of Lilly's trial, which differed significantly from the trial design of Eisai and Biogen Leqembi, which won U.S. approval after going through a similar advisory committee meeting.

Both the drugs are designed to remove toxic beta amyloid plaques from the brains of people with early Alzheimer's disease. The antibody treatments, which succeeded in slowing disease progression in clinical trials, follow three decades of failed attempts to find drugs to fight the fatal mind-wasting disease. Several panelists after the vote noted that underlying data looking at levels of amyloid suggest the treatment is likely to benefit people with early Alzheimer's, including people with no or low levels of tau in their brain who were not included in the study population.

The FDA had been expected to rule on the drug earlier this year but called for the meeting so its independent panel of experts could weigh in. The agency is not obligated to follow the recommendations of its outside advisers, but typically does so. Shares of the U.S. drugmaker were up 2.3% at $869.3 in afternoon trading.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)