Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration has rejected accelerated approval of its experimental Alzheimer’s drug because it did not submit enough trial data from patients who were treated for at least 12 months.
Lilly said the FDA sent it a complete response letter for donanemab, an antibody designed to remove amyloid protein plaques from the brains of people with early Alzheimer’s. Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval.
Lilly said the FDA issued the letter “due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.”
The company said it remained on track to report in the second quarter of this year results from a confirmatory Phase 3 trial of donanemab. That study, Lilly said, will form the basis of donanemab’s application for traditional FDA approval shortly thereafter.