Yahoo Finance FDA panel votes unanimously for Eli Lilly's Alzheimer's treatment
An FDA panel voted 11-0 Monday to recommend the use of Eli Lilly's (LLY) early-stage Alzheimer's treatment, known as donanemab.
The monoclonal antibody drug, delivered through an IV monthly for up to 18 months, would be the second Alzheimer's drug on the market if the FDA moves ahead to approve. The FDA's decision does not have to align with the panel's vote.
During the panel hearing Monday, experts discussed the safety of the product, as there were a number of deaths reported during the trial, and the potential for use only within certain subgroups as a result.
The trial studied the drug's ability to address beta-amyloid plaque buildup associated with dementia and the ability to slow progress of the disease in patients between the ages of 60 and 85. Lilly's results showed a 35% reduction in progress of the disease in 18 months.
The only other drug on the market currently is Eisai and Biogen's (BIIB) Leqembi, which showed a 27% decline in progression of the disease in patients who used it for 18 months.
There were also adverse events reported in 21% of patients. This had been a concern for doctors during Leqembi's predecessor which had a disastrous rollout and was eventually taken off the market.
Leqembi has struggled to take off due to burdensome Medicare rules for use — including expensive brain scans — as well as skepticism about its benefits from doctors. Medicare is also concerned about the cost, estimating $3.5 billion will be spent on Alzheimer's drugs in 2025.
Eisai and Biogen have also asked the FDA to approve an injectable version of the drug, which would make it easier for patients to access.
Eisai also announced Sunday it had filed for extended use of the IV version of Leqembi after the initial 18-month treatment period to ensure continued support against progression of the disease. The FDA accepted the request on Monday and has until January 2025 to make a decision.
The timeline for Lilly's donanemab approval, initially expected by the end of the first quarter of this year, has been delayed. The FDA has not updated its anticipated action date to approve or reject the drug.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.
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