11:01 AM EST, 03/08/2024 (MT Newswires) -- Eli Lilly and Co. ( LLY ) said Friday that its Alzheimer's Disease drug candidate donanemab will be delayed beyond the first quarter as the US Food and Drug Administration convenes a surprise meeting to gather more information about a late-stage trial.

The regulatory body is expected to convene a meeting with the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the Phase 3 trial that evaluated the treatment's efficacy and safety in patients with early symptomatic Alzheimer's disease, Lilly said in a statement.

The FDA told Lilly it wants to further understand topics related to evaluating donanemab's efficacy and safety, including the efficacy of the trial design and its limited-duration dosing regimen, according to the company.

Since a date of the advisory committee meeting has yet to be set, FDA action on donanemab, which had been expected before the end of the first quarter, will be further delayed, the company said. Shares of Lilly slipped 1.2% in morning trade.

While it's unusual for the FDA to convene an advisory committee meeting after its anticipated action date, Lilly said the US regulatory group has conducted similar meetings for two other amyloid plaque-targeting therapies that went on to receive FDA approval. An FDA spokesperson told MT Newswires the agency cannot comment on possible or pending product applications or approvals.

"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," Lilly Neuroscience President Anne White said.

The company remains confident in donanemab's potential to offer meaningful benefits to people with early symptomatic Alzheimer's disease and will work with the FDA to answer all questions, she said. Lilly on Friday reiterated its 2024 financial guidance.

Lilly has said donanemab significantly slowed Alzheimer's progress in the late-stage trial, with all trial participant groups benefiting from the treatment. A key risk, like other amyloid-lowering drugs, is amyloid-related imaging abnormalities, which led to serious outcomes such as hospitalization in 1.6% of trial participants.

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