Eli Lilly’s Alzheimer's Drug Gets Key FDA Panel Endorsement

A federal health advisory panel endorsed a new Alzheimer’s drug from Eli Lilly, setting the stage for approval. Despite some risks, the panel deemed the benefits significant. The FDA will make the final decision later this year. If approved, it will be the second drug in the U.S. to slow Alzheimer’s progression.

An Alzheimer's drug developed by Eli Lilly has received backing from a federal health advisory panel, potentially paving the way for its approval for patients with mild dementia. In a unanimous vote, the Food and Drug Administration (FDA) advisers concluded that the drug's ability to modestly slow Alzheimer's outweighs risks, such as brain swelling and bleeding, which will need careful monitoring.

''The evidence was very strong in the trial showing the effectiveness of the drug,'' commented Dean Follmann, a National Institutes of Health statistician and panel member. The FDA's final decision is expected later this year. If the drug, donanemab, gets approved, it would be the second Alzheimer's drug in the U.S. proven to slow cognitive decline and memory loss.

Lilly's study divided patients based on levels of tau, a brain protein indicating cognitive problem severity. Although some panelists questioned the necessity of requiring tau screening for patients, most agreed there was sufficient evidence to prescribe the drug broadly. Dr. Thomas Montine of Stanford University, who chaired the panel, noted that a requirement for tau imaging was not essential and would complicate access to the treatment.

Lilly's trial showed that patients receiving monthly infusions of donanemab declined cognitively about 35 percent slower than those on a sham treatment. While there were other questions about generalizing these results to all patients, the panel found enough data to support the drug's widespread benefit.

Experts acknowledged that stopping doses when brain plaque levels drop, a feature unique to Lilly's treatment, could reduce long-term costs and side effects. Yet, FDA staff pointed out that Lilly had limited data on optimal treatment duration. Despite these concerns, panelists like Dr. Tanya Simuni of Northwestern University saw potential cost savings, emphasizing the need for ongoing patient monitoring.

The main safety issues include brain swelling and bleeding, common among amyloid-targeting drugs, with slightly higher rates reported in Lilly's study than in competing treatments. Three deaths in the study were linked to brain swelling or bleeding, raising the importance of warnings for doctors and risk management strategies.