Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease

Core Viewpoint - Eli Lilly and Company has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending donanemab for the treatment of early symptomatic Alzheimer's disease, with a regulatory decision from the European Commission expected soon [1][2]. Company Summary - Eli Lilly emphasizes the significance of this positive opinion as a milestone in making donanemab available to eligible patients in Europe, highlighting its potential to significantly impact those living with early symptomatic Alzheimer's disease [2]. - The company is committed to advancing scientific research through ongoing clinical trials and programs related to donanemab [2]. - Donanemab is currently marketed as Kisunla in various countries, including the United States, Japan, and the United Kingdom, and is approved for patients regardless of ApoE4 status in many regions [4]. Industry Summary - Alzheimer's disease currently affects approximately 6.9 million people in Europe, with projections indicating this number could nearly double by 2050 due to aging populations [2]. - Clinical trial data from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies support the efficacy of donanemab in slowing cognitive decline and reducing the risk of disease progression [2]. - The TRAILBLAZER-ALZ 6 trial demonstrated that a modified dosing schedule for donanemab significantly reduced the incidence of amyloid-related imaging abnormalities (ARIA-E) while maintaining similar levels of amyloid plaque removal [2].