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

June 24, 2021 6:46 AM EDT

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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 for donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG. The company's Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic AD. These data were presented at the 15th International Conference on Alzheimer's & Parkinson Diseases™ 2021 (AD/PD™ 2021) and published simultaneously in the New England Journal of Medicine.

Lilly intends to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing randomized, placebo-controlled, double-blind, multi-center Phase 3 study TRAILBLAZER-ALZ 2 (NCT04437511).

To learn more about the TRAILBLAZER-ALZ 2 study or to see if you prequalify, visit http://www.trailblazer2study.com.



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