The U.S. Food and Drug Administration has granted a Breakthrough Therapy designation for donanemab, an antibody therapy for the treatment of Alzheimer’s disease from Indianapolis Eli Lilly and Co. (NYSE: LLY). The designation aims to expedite the development and review of drugs that are intended to treat a serious condition.
Lilly says the designation is based on clinical evidence for donanemab, which 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.
Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year.
You can learn more about the TRAILBLAZER-ALZ 2 study or to see if you prequalify by clicking here.