08:52 AM EST, 03/08/2024 (MT Newswires) -- Eli Lilly ( LLY ) said Friday that the US Food and Drug Administration will call an advisory committee meeting to discuss the phase 3 Trailblazer-Alz 2 trial of donanemab in early Alzheimer's disease.

The regulator needs additional understanding of topics regarding the safety and efficacy of donanemab, the company added.

Eli Lilly ( LLY ) also said that the FDA has not yet decided on the date of the advisory meeting with the Peripheral and Central Nervous System Drugs Advisory Committee.

The timing of the regulator action on donanemab will likely be delayed beyond Q1, the medicine company said, but will not impact the company's 2024 financial outlook.

Shares of Eli Lilly ( LLY ) were down 0.7% in recent Friday premarket activity.

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