In a recent announcement, Eli Lilly has stated that it has received the FDA's Breakthrough Therapy designation for donanemab, which is an investigational antibody therapy for Alzheimer's disease. The announcement follows a Phase 2 clinical trial that primarily focused and studied the safety and effectiveness of the drug in patients with early, symptomatic Alzheimer's disease. Breakthrough Therapy designation aims to accelerate the development and review of drugs intended to treat a serious condition.
Eli Lilly, in its news release, said that it plans to submit the drug for FDA Accelerated Approval by the end of this year. The drug predominantly targets a beta-amyloid protein in the brain, and it is currently being assessed in an ongoing Phase 3 clinical trial known as TRAILBLAZER-ALZ 2. Eli Lilly has reported that the first patients outside of clinical trials received the drug.
The FDA's came in subsequently several weeks after the agency granted Biogen's Alzheimer's drug accelerated approval. Aduhelm became the first Alzheimer's drug to receive approval in nearly two decades, but the drug received mixed reviews from scientists. The Peripheral and Central Nervous System Drugs Advisory Committee has stated that it was not reasonable to consider the drug's clinical benefit based on one successful study.