Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease

Core Insights - Eli Lilly and Company has received marketing authorization from the European Commission for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease, specifically in adults with mild cognitive impairment and mild dementia stages with confirmed amyloid pathology [1][4][5] - Kisunla has shown significant efficacy in slowing cognitive and functional decline in patients, particularly when treatment is initiated early [2][3] - The therapy is unique as it allows for the completion of treatment once amyloid plaques are reduced to minimal levels, potentially lowering treatment costs and reducing the burden of infusions [3][8] Group 1: Efficacy and Treatment Details - Kisunla demonstrated meaningful results in slowing cognitive and functional decline in the Phase 3 TRAILBLAZER-ALZ 2 study, with earlier treatment correlating with better patient outcomes [2][5] - The treatment can help remove excessive amyloid plaques, which are linked to memory and cognitive issues associated with Alzheimer's disease [2][3] - Kisunla is the only once-monthly therapy that supports completing treatment after achieving minimal amyloid levels, which may reduce overall treatment costs [3][8] Group 2: Market Context and Need - 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 [4] - There is a critical need for early detection and treatment, as about one-third of individuals in early symptomatic stages may progress to more advanced stages within a year [4][5] - The marketing authorization is based on the results from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials, which evaluated the safety and efficacy of Kisunla [5][9] Group 3: Safety and Side Effects - Kisunla may cause Amyloid-Related Imaging Abnormalities (ARIA), which can be serious but often asymptomatic; monitoring through MRI is recommended during treatment [6][12] - The incidence of ARIA can be reduced with a gradual titration dosing schedule, as demonstrated in the TRAILBLAZER-ALZ 6 study [6][9] - Patients with a genetic predisposition (ApoE4 carriers) may be at higher risk for ARIA and should discuss safety concerns with healthcare providers [6][13]