A panel of independent advisors to the Food and Drug Administration recommended Eli Lilly’s Alzheimer’s drug donanemab on Monday, potentially paving the way for its full approval in the U.S. later this year. Although the FDA usually follows its advisory panels’ recommendations, it is not required to do so. If approved, donanemab would become the second Alzheimer’s drug of its kind on the U.S. market, following Leqembi from Biogen and its Japanese partner Eisai.
Approval of donanemab would significantly expand treatment options for the over 6 million Americans suffering from Alzheimer’s, the fifth-leading cause of death for adults over 65. The advisory panel’s first vote saw all 11 members unanimously agree that the available data shows the drug is effective for treating Alzheimer’s patients in the early stages of the disease. However, several advisors emphasized the need for more data on donanemab in Black and Hispanic patients and other groups.
In a second unanimous vote, the advisors agreed that the benefits of donanemab outweigh its risks. “There’s a huge unmet medical need here that hopefully can be addressed,” said Sarah Dolan, a temporary committee member and consultant for the non-profit organization Critical Path Institute, during the meeting on Monday. Mark Mintun, group vice president of neuroscience research and development at Eli Lilly, expressed the company’s satisfaction with the panel’s recommendation and eagerness to bring the treatment to patients.
Eli Lilly faced challenges in bringing donanemab to market. In March, the FDA called a last-minute meeting to further review the drug’s safety and efficacy in a late-stage trial, just weeks before the agency’s deadline to rule on the treatment. This followed an initial expectation for approval at the end of last year and a rejection in January due to insufficient data.
The FDA’s cautious approach to donanemab follows the polarizing approval of Aduhelm, another Alzheimer’s drug from Biogen and Eisai, which was granted accelerated approval despite a negative advisory panel recommendation. Aduhelm was eventually dropped by its developers.
Leqembi and donanemab represent significant milestones in Alzheimer’s treatment after decades of failed efforts. Both drugs are monoclonal antibodies targeting amyloid plaque in the brain, a hallmark of Alzheimer’s, to slow disease progression in early-stage patients. However, neither drug is a cure. Targeting and clearing amyloid plaque can cause severe side effects, including brain swelling and bleeding. In a late-stage trial, three patients taking donanemab died from these side effects, known as amyloid-related imaging abnormalities (ARIA).
Despite the hurdles in rolling out Leqembi, including diagnostic and monitoring requirements, Biogen and Eisai have seen adoption picking up. Analyst David Risinger of Leerink Partners expects limited commercial adoption of donanemab relative to Leqembi due to greater safety liabilities and less convenient monthly intravenous infusions. Leqembi currently requires twice-monthly infusions, with an injectable version expected next year. Risinger projects donanemab could achieve $500 million in sales by the end of the decade.
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