Eli Lilly reports that the U.S. Food and Drug Administration (FDA) plans to convene its Peripheral and Central Nervous System Drugs (PCNS) Advisory Committee on June 10 to discuss the company's application for donanemab as a potential treatment for Alzheimer's disease.

The application was based on the results of a Phase III study evaluating the safety and efficacy of donanemab in 1736 participants from eight countries, aged 60 to 85, with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with confirmed neuropathology.

The results of the study (TRAILBLAZER-ALZ 2) were published in the Journal of the American Medical Association (JAMA).

The company says it will continue its study of donanemab, notably via the so-called TRAILBLAZER-ALZ-3 trial, which will look at donanemab as a potential preventive treatment for Alzheimer's disease.

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