Donanemab for the treatment of Alzheimer disease has received Breakthrough Therapy designation from the FDA.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's investigational antibody therapy for Alzheimer disease (AD).1
Donanemab, a monoclonal antibody, was designed to target a particular form of post-translationally modified Aß, N-terminal pyroglutamate, and completely clear amyloid plaques.2
The Breakthrough Therapy designation, created to expedite the development of drugs meant to treat serious conditions when preliminary evidence suggests the drug may demonstrate substantial improvements over already available therapies that have full FDA approval, is based on clinical evidence from Eli Lilly and Company’s phase 2 trial, TRAILBLAZER-ALZ for donanemab.
TRAILBLAZER-ALZ studied the efficacy and safety of donanemab in patients with early, symptomatic AD. 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.
Data were published in the New England Journal of Medicine.
“At 76 weeks, the reductions in the amyloid plaque level and the global tau load were 85.06 centiloids and 0.01 greater, respectively, with donanemab than with placebo,” wrote the study’s authors.3
Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later in 2021.
1. Eli Lilly and Company. Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease. News release. June 24, 2021. Accessed June 25, 2021. https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-receives-us-fdas-breakthrough-therapy
2. Kuntz L. New data for Alzheimer agent presented at international conference. Psychiatric Times. March 23, 2021. Accessed June 25, 2021. https://www.psychiatrictimes.com/view/new-data-for-alzheimer-agent-presented-at-international-conference
3. Mintun MA, Lo AC, Evans CD, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. 2021;384:1691-1704.