Eli Lilly's Donanemab For Alzheimer's Hits FDA Speed Breaker, Biogen Stock Gains On Delayed Decision

The FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly and Company’s LLY Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease. 

The FDA has informed Lilly that it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.

The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024. 

While it is unusual for an advisory committee to occur after the anticipated FDA action date, the advisory committee meeting for donanemab follows similar meetings for the two other amyloid plaque-targeting therapies the FDA has approved.

“We are confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease. It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab’s strong efficacy in the context of safety,” said Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience.

Biogen Inc BIIB shares are trading higher in reaction to the FDA delaying its decision for Eli Lilly’s Alzheimer’s drug.

Donanemab would compete with Eisai Co Ltd ESALY/Biogen’s Leqembi, for which the FDA granted standard authorization last year.

Read Next: Analysts Say Eli Lilly’s Donanemab In Alzheimer’s Is Encouraging, Outline Potential Implications For Biogen.

Price Action: LLY shares are down 0.64% at $775.16, and BIIB stock is up 3.73% at $227.55 during the premarket session on the last check Friday.

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