By Dave Sebastian
Eli Lilly & Co. said it has received breakthrough therapy designation for its Alzheimer's treatment from the U.S. Food and Drug Administration.
The designation means preliminary clinical evidence indicates the drug could show substantial improvement over available therapies on a clinically significant endpoint, and is meant to expedite the development and review of drugs for serious conditions, according to the FDA.
Lilly on Thursday said it plans to submit a biologics license application for the drug, donanemab, under the accelerated approval path later this year based on data from its Phase 2 trial. It said the safety, tolerability and efficacy of donanemab are being evaluated in an ongoing Phase 3 study.
Write to Dave Sebastian at email@example.com
(END) Dow Jones Newswires