European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend Eli Lilly and Company’s (NYSE:LLY) donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. Lilly will seek re-examination by CHMP.
“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,” said Ilya Yuffa, executive vice president and president of Lilly International. “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.”
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