Eli Lilly Gets Breakthrough Therapy Designation for Alzheimer's Treatment From FDA
June 24 2021 - 7:18AM
Dow Jones News
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 dave.sebastian@wsj.com
(END) Dow Jones Newswires
June 24, 2021 07:13 ET (11:13 GMT)
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