The Peripheral and Central Nervous System Drugs Advisory Committee by a unanimous vote confirmed the efficacy and safety of Eli Lilly and Company’s (NYSE: LLY) donanemab for the treatment of early symptomatic Alzheimer’s disease, which includes mild cognitive impairment (MCI) or mild dementia stage of the disease.
“We are pleased with the committee’s unanimous recognition of donanemab’s positive benefit-risk profile,” said Mark Mintun, group vice president of neuroscience research and development for Eli Lilly and Company. “We look forward to bringing this treatment option to patients.”
The committee’s discussion was based on the donanemab TRAILBLAZER-ALZ 2 Phase 3 results, which were published in the Journal of the American Medical Association (JAMA), additional supporting studies, and data from the large safety database.
