Eli Lilly and Company’s (LLY) donanemab is not recommended for marketing authorization for the treatment of early symptomatic Alzheimer’s disease, according to an opinion released by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Lilly will ask CHMP to re-examine.
Europeans living with early symptomatic Alzheimer’s disease and their loved ones urgently need additional treatment options. Today’s disappointing CHMP opinion means they must keep waiting,
Donanemab has been reviewed and approved in the United States, Japan, China, and other markets. Lilly remains confident in the safety and effectiveness of donanemab and the value it can bring to patients with early symptomatic Alzheimer’s disease. We hope that through the re-examination process, we will be able to continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease.
Ilya Yuffa
Kisunla (donanemab-azbt)
Kisunla (donanemab-azbt) is used to treat persons who have moderate cognitive impairment (MCI) or mild dementia, which are early symptoms of Alzheimer’s disease (AD).
Source: Eli Lilly and Company
