Mark your calendars: Eli Lilly will come before the FDA’s advisory committee to discuss Alzheimer’s disease medicine donanemab June 10.
The Peripheral and Central Nervous System Drugs Advisory Committee will meet from 9 a.m. to 5 p.m. ET on that date to discuss the application for donanemab in early symptomatic Alzheimer’s, Lilly announced in a Tuesday statement. The meeting will be held virtually and is open to the public.
The exact questions to be discussed are not yet known, but, as always, the FDA will publish its materials (PDF) for the meeting two days beforehand, which will include the voting questions and the agency’s take on the issues. Lilly will also provide a rebuttal.
Speaking to Fierce Biotech last month, executives from Lilly said the issues are likely to surround labeling for donanemab. The FDA has balked at the fact that patients stopped taking the therapy once they achieved amyloid clearance, as seen on imaging tests.
Since this is a change in the standard of care for Alzheimer’s, where patients typically take a drug for the rest of their lives to manage their condition, the FDA wants to learn more, Dawn Brooks, Ph.D., Lilly’s global development leader for donanemab and the pharma’s other lead Alzheimer’s drug remternetug, said last month.
Another issue that could come into play is that Lilly screened patients for tau levels on trial entry, but the pharma insists this will not need to be done for everyday use. Either way, the drug showed effect across tau levels in the sprawling TRAILBLAZER program that was used to underpin the application for donanemab.