Lilly's Donanemab Gets Positive CHMP Opinion In Early Symptomatic Alzheimer's Disease

(RTTNews) - Eli Lilly and Company (LLY) Friday said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for donanemab for the treatment of early symptomatic Alzheimer's disease.

The positive opinion was primarily based on data from the TRAILBLAZER-ALZ 2 study, which showed donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next stage of disease, as well as the TRAILBLAZER-ALZ 6 study evaluating a modified titration dosing schedule. Donanemab, marketed as Kisunla, is approved for the treatment of early symptomatic Alzheimer's disease in several countries including U.S, U.K, Japan, and China among others.