Lilly Announces Positive Phase 3 Results for Donanemab in Early Alzheimer's Disease, Awaiting FDA Decision by Year-End

On July 17 local time, the Phase 3 clinical trial TRAILBLAZER-ALZ 2 study results published on the official website of Eli Lilly and Company showed that donanemab significantly slowed cognitive and functional decline in patients with early symptoms of Alzheimer's disease and delayed disease progression. These data were shared at a symposium of the 2023 Alzheimer's Association International Conference (AAIC) and simultaneously published in the Journal of the American Medical Association (JAMA). Eli Lilly completed the submission of its New Drug Application to the U.S. FDA in the second quarter of this year and expects to receive the review results by the end of this year.