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Lilly's (LLY) donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease

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Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease

June 24, 2021 6:45 AM EDT

INDIANAPOLIS, June 24, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD). The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

The FDA Breakthrough Therapy designation is based on clinical evidence... More