An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration advisory panel on Monday. Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia. At the FDA's Peripheral and Central Nervous System Advisory Committee hearing, which was held in Maryland on Monday, the advisers unanimously agreed that the drug’s benefits outweigh any potential risks.
While this isn’t a guarantee the FDA will approve the drug, the agency does typically follow the panel’s recommendations, per reports. Officials at Eli Lilly, the Indiana pharmaceutical company that makes donanemab, were also in attendance, fielding questions from the committee about potential side effects.
In phase 3 trials published in May 2023, donanemab was shown to 'significantly slow cognitive and functional decline in people with early symptomatic Alzheimer's disease,' according to a press release on Eli Lilly’s website. If donanemab is approved, it would become only the second available medication designed to slow the progression of Alzheimer’s symptoms. Leqembi, the first new Alzheimer’s treatment in 20 years, was given full FDA approval in July 2023.