FDA sets AdCom on donanemab for Alzheimer’s for June 10

Following a couple of delays on reviewing US pharma major Eli Lilly’s (NYSE: LLY) marketing application for its Alzheimer’s disease candidate donanemab, the US Food and Drug Administration (FDA) has now said it will convene an in person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on June 10, 2024, to discuss the drug.

The open public hearing portion of the meeting will be conducted virtually.

Lilly says that the Phase III study submitted as part of this application, TRAILBLAZER-ALZ 2, is a double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants ages 60-85 years with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology.