Lilly to discuss Alzheimer's drug donanemab with FDA

Eli Lilly is set to present its Alzheimer’s disease medication, donanemab, to the FDA’s advisory committee on June 10. The Peripheral and Central Nervous System Drugs Advisory Committee will convene from 9 a.m. to 5 p.m. ET to discuss the application of donanemab for early symptomatic Alzheimer’s, as announced by Lilly in a statement released on Tuesday. This meeting will be conducted virtually and will be accessible to the public.

While the specific topics for discussion at the advisory committee meeting have yet to be disclosed, the FDA is expected to release its briefing documents, including voting questions and the agency's perspectives, two days prior to the meeting. Eli Lilly will also provide a counterargument to the FDA's points.

In a previous discussion with Fierce Biotech, Lilly executives mentioned that the primary concerns likely to be addressed will pertain to the labeling for donanemab. The FDA has expressed concerns regarding the discontinuation of the therapy by patients once they achieve amyloid clearance, as evidenced by imaging tests. This approach deviates from the standard treatment for Alzheimer’s, where patients typically continue their medication indefinitely to manage their condition. Lilly’s global development leader for donanemab, Dawn Brooks, Ph.D., noted last month that the FDA seeks to understand this change in treatment protocol better.

Another potential issue that may be raised is related to the screening of patients for tau levels during the trial entry phase. Despite this, Lilly maintains that such screening will not be necessary for the regular use of donanemab. The drug demonstrated effectiveness across different tau levels in the extensive TRAILBLAZER program, which forms the basis for its application.

The upcoming meeting will be crucial as it will determine the future of donanemab in the treatment landscape for early symptomatic Alzheimer’s. The discussions and outcomes of this meeting will be closely watched by various stakeholders, including healthcare professionals, patients, and investors, given the significant interest in new treatment options for Alzheimer’s disease.