Outside advisers to the U.S. Food and Drug Administration on Monday voted unanimously that the benefits of Eli Lilly's experimental Alzheimer's treatment donanemab outweighed its risks, and agreed that trial data showed it was effective in patients with an early stage of the memory-robbing disease.
4 View gallery Alzheimer's ( Photo: Shutterstock ) The vote clears the way for a final FDA decision on the treatment, which initially had been expected earlier this year before the agency called for the meeting so its independent panel of experts could weigh in. "We really are pleased that the advisory committee recognized donanemab's strong positive benefit-risk," Dawn Brooks, Lilly's development leader for donanemab, said in an interview after the vote. Now with the panel's unanimous support, the company looks forward to the FDA finishing its review, she said.
The agency is not obligated to follow the recommendations of its outside advisers but typically does so. In its discussion, the FDA had asked the panel to consider 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 drugs are designed to remove toxic beta-amyloid plaques from the brains of people with early Alzheimer's disease. 4 View gallery New drug can battle Alzheimer's ( Photo: Shutterstock ) The antibody treatments, which succeeded in slowing disease progression in cl.
