STAT+: FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment
Advisers to the Food and Drug Administration voted 11-0 on Monday to recommend the approval of a drug for early Alzheimer’s disease made by Eli Lilly — ruling that the treatment’s ability to slow the cognitive decline in patients outweighed its safety risks.
The unanimous outcome of the day-long advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s. A decision is expected later this year.
“The benefits outweigh the risks, as long as the risks are being monitored,” said Kathleen Poston, a neurologist at Stanford University and a member of the advisory panel.
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