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FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.
FDA has granted breakthrough therapy designation for donanemab, Eli Lilly and Company's (Lilly’s) investigational antibody therapy for Alzheimer's disease (AD), Lilly announced on June 24, 2021. The designation is based on clinical evidence for the antibody, which targets a modified form of beta amyloid called N3pG.
A Phase II trial studied the efficacy and safety of donanemab in patients with early, symptomatic AD, and data were presented at the 15th International Conference on Alzheimer's & Parkinson Diseases 2021 as well as published simultaneously in the New England Journal of Medicine (1).
Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from this Phase II trial. The company is also conducting a Phase III study to evaluate the safety, tolerability, and efficacy of donanemab.
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.
1. M.A. Mintun, et al., N Engl J Med 384, 1691–1704 (2021).
Source: Eli Lilly and Company