FDA Panel Backs Eli Lilly’s Alzheimer’s Drug Donanemab, Potential Approval Expected

A panel of independent advisors to the Food and Drug Administration (FDA) has recommended the approval of Eli Lilly’s Alzheimer’s drug donanemab, potentially clearing the path for its full approval in the U.S. later this year. If approved, donanemab would become the second drug of its kind on the U.S. market, following Leqembi from Biogen and Eisai.

Related article: Eisai and Biogen’s Alzheimer’s Med, Leqembi, Granted FDA Approval

On June 10, 2024, the FDA advisory panel unanimously voted that the benefits of donanemab outweigh its risks. This recommendation is significant for the more than six million Americans aged 65 and older living with Alzheimer’s in 2023, a disease with limited treatment options and no cure. Eli Lilly’s drug aims to modestly slow cognitive decline in early-stage Alzheimer’s patients

Mark Mintun, Group Vice President of Neuroscience Research and Development at Eli Lilly, expressed optimism about the panel’s recommendation. “We are pleased with the panel’s recommendation and look forward to bringing the treatment to patients,” Mintun said in a statement reported by CNN.

The advisory committee’s decision was based on evidence showing that donanemab can slow disease progression by 29% compared to a placebo over 18 months. However, the drug also carries significant risks, including brain swelling and bleeding. Approximately 24% of trial participants experienced brain swelling, while 31% experienced brain bleeding, with serious cases occurring in a small percentage of patients. These risks highlight the need for caution, and the FDA is expected to require a strong “boxed” warning on donanemab’s label.

According to Eli Lilly, nearly half (47%) of the participants on donanemab (compared to 29% on placebo) had no clinical progression at one year, defined as no decline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB). The Phase 3 trial met its primary endpoint and all secondary endpoints measuring cognitive and functional decline.

Donanemab treatment slowed clinical decline by 35% compared to placebo and resulted in 40% less decline in the ability to perform activities of daily living. Over half of all participants completed their course of treatment by 12 months.

Sarah Dolan, a temporary committee member and consultant for the non-profit organization Critical Path Institute, also highlighted the significance of the recommendation. “There’s a huge unmet medical need here that hopefully can be addressed,” Dolan said, according to CNN.

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If approved, donanemab would join Leqembi as a pioneering treatment for Alzheimer’s. Both drugs target amyloid plaques in the brain, a hallmark of Alzheimer’s, to slow disease progression, though neither drug cures the disease. Approval of donanemab could offer hope to millions of Alzheimer’s patients and their families, providing a new option in the fight against this debilitating condition. The FDA typically follows the recommendations of its advisory panels but is not required to do so. The final decision by the FDA is highly anticipated and could come later this year.

Other references: 

1. CNBC
2. The New York Times
3. Reuters

Author

Diana Shih