European Drug Regulator Gives Thumbs Down To Eli Lilly's Alzheimer's Drug, Analyst Says It Is Incremental Win For Biogen

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend Eli Lilly and Co's (NYSE:LLY) donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. Lilly will seek re-examination by CHMP.

Kisunla (donanemab) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

Also Read: Alzheimer's Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding

In October 2024, Eli Lilly released results from the TRAILBLAZER-ALZ 6 Phase 3b study to investigate different dosing regimens of donanemab and their effect on amyloid-related imaging abnormalities with edema/effusion (ARIA-E) in adults with early symptomatic Alzheimer's disease.

The data ...