Eli Lilly Alzheimer's drug rejected by EU regulator

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-31T17:20:38+05:30 | Updated On 31 March 2025 5:20 PM IST

Indianapolis: Indianapolis-based pharmaceutical giant Eli Lilly has faced a setback as the European Union's drug regulator rejected its Alzheimer's drug, citing that the drug's limited impact on slowing cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.

"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 donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. Lilly will seek re-examination by CHMP," the Company stated in a release.

The regulator stated that the drug's small impact on slowing cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.

“Europeans living with early symptomatic Alzheimer’s disease and their loved ones urgently need additional treatment options. The 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.”

The rejection of the drug, Kisunla, means Eisai and Biogen's Leqembi will likely pull ahead in the race to become the EU's first approved Alzheimer's treatment, if the European Commission accepts the agency's recommendation on the rival drug.

The EU regulator's Committee for Medicinal Products for Human Use (CHMP) in February reiterated its positive recommendation for Leqembi after concluding a safety review.

Kisunla and Leqembi achieved the long-awaited breakthrough after decades of failed attempts to find drugs to combat the fatal mind-wasting disease.

However, health regulators, wary of the risk of serious brain swelling and bleeding, have been particularly rigorous during the review process.

The CHMP recommended approval for Leqembi last year, after previously rejecting the treatment, saying the drug's ability to slow cognitive decline did not outweigh the health risks.

The EMA recommended Leqembi's use in a narrower set of patients - with one or no copy of a gene variant called ApoE4 - who are less likely to experience the serious side effects.

The EU medical regulator is far too slow compared with regulators in other countries, including the United States and Japan, in reviewing and authorizing breakthrough new treatments, Lilly's Yuffa said in a statement shared with Reuters after the decision.

He criticized the medical regulatory environment in Europe, saying it was discouraging drugmakers from doing research and development on the continent.

The European Commission proposed its first overhaul of the bloc's pharma regulation rules in 20 years two years ago, but that bill has not been passed into law by parliament.

The Commission said at the time that the new rules were meant to make it easier for innovative drugs to reach patients more quickly and in all European nations, but the pharma industry has said the rules would have the opposite effect of discouraging innovation

There are about 7 million people with Alzheimer's disease in Europe, according to the European Brain Council.

eli lillyeli lilly newalzheimers drugEuropean Medicines AgencydonanemabKisunla

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751