Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year.
Lilly said the FDA had 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.
"I don't think it says anything negative about the drug. It was just a manifestation of the study design," said Dr. Ronald Petersen, an Alzheimer's expert at the Mayo Clinic in Rochester, Minnesota. "I don't see this is an impediment to the process or timeline in any way," said Dr. Eric Reiman, executive director of Banner Alzheimer's Institute. "When the Phase 3 trial reads out, I understand it will have that safety data in at least 100 people."
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