The United States Food and Drug Administration (FDA) unanimously approved this Monday that the benefits of donanemab, Eli Lilly’s experimental treatment against Alzheimer’s, outweighed its risks, and agreed that the data from … The trials showed its effectiveness in patients with an early phase of the disease that destroys memory.
The vote clears the way for a final FDA decision on the treatment, which was initially expected earlier this year before the agency called the meeting so its independent panel of experts could weigh in.
“We are really pleased that the advisory committee recognized the strong positive benefit of donanemab,” said Dawn Brooks, head of drug development at Lilly, in an interview after the vote. Now, with the panel’s unanimous support, the company hopes the FDA will complete its review, she said.
It was in July 2023, when Eli Lilly showed that its experimental drug showed better results by treating Alzheimer’s patients as early as possible, ideally before they develop symptoms of this brain-destroying disease, researchers said Monday. a promising new advance to treat the most common form of dementia.
Disease slowed by up to 60%
Donanemab has been shown to slow the progression of memory and thinking problems by about a third, but that percentage doubles to 60% if the drug is started when patients have only mild impairment, according to a trial presented at the Alzheimer’s Association International Conference in Amsterdam. This new Lilly drug is a potential rival to Biogen’s Eisai and Leqembi, which won U.S. approval in July.
