US EditionEuropean committee says Lilly Alzheimer’s drug shouldn’t get marketing approval
- On March 28 2025, a European regulatory committee rejected Eli Lilly's marketing authorisation application for Kisunla , a U.S.-approved Alzheimer's disease treatment, for use in Europe.
- The rejection by the European Medicines Agency's Committee for Medicinal Products for Human Use stemmed from concerns that the benefits of Kisunla, designed to slow disease progression by targeting amyloid plaque buildup, did not outweigh the risks of potentially dangerous side effects such as brain bleeding and swelling .
- While clinical trials showed Kisunla slowed cognitive decline by up to 35% over 18 months compared to a placebo, serious ARIA events and three related deaths in the Kisunla group raised safety concerns, even though Kisunla has already been approved in the U.S. , Japan, and China for mild or early cases of dementia.
- Ilya Yuffa, executive vice president at Lilly, stated, "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," also adding that "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."
- The CHMP's negative opinion means that Europeans with early Alzheimer's disease may not have access to an additional anti-amyloid treatment, leading to criticism from Alzheimer Europe, which expressed regret and hoped for EMA reconsideration based on real-world studies, while also acknowledging the CHMP's attention to patient safety during evaluations.
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European Drug Regulator Gives Thumbs Down To Eli Lilly's Alzheimer's Drug, Analyst Says It Is Incremental Win For Biogen - Eli Lilly (NYSE:LLY)
Eli Lilly's donanemab faces a setback as EMA's CHMP issues a negative opinion. Analysts expect Lilly to appeal, citing past reversals in similar cases. Latest Ratings for LLY DateFirmActionFromTo Feb 2022Morgan StanleyMaintainsOverweight Feb 2022MizuhoMaintainsBuy Jan 2022Morgan StanleyMaintainsOverweight View More Analyst Ratings for LLY View the Latest Analyst Ratings
·New York, United States
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Dementia: Why the EMA does not release new Alzheimer's drug
More than one million people in Germany alone are waiting for a remedy against Alzheimer's disease. For example, the active substance Donemab is supposed to slow down the course of the disease. However, the EU pharmaceutical authority EMA is not convinced of the drug.
·Dortmund, Germany
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