The European Medicines Agency committee declined approval for Eli Lilly's Alzheimer's disease medication, Kisunla, due to potential risks of brain bleeding and swelling. The committee stated that the risks associated with the drug outweighed its benefits, leading to the recommendation of withholding marketing authorization.

Eli Lilly has the option to request a re-evaluation of the committee's decision. The company expressed hope for continued discussions with the agency during the re-examination process, highlighting that Kisunla has already received approval in countries like Japan and China.

In the United States, Kisunla was granted approval for mild or early-stage dementia linked to Alzheimer's, following a similar approval for Leqembi from Japanese drugmaker Eisai. These drugs have been the first to exhibit a delay in cognitive decline in patients, though the extension is limited to a few months.

Last summer, the European committee also initially rejected approval for Leqembi due to similar concerns but later reversed its decision. Both Kisunla and Leqembi are synthetic antibodies administered intravenously to target amyloid plaques in the brain, a key component of Alzheimer's disease. Uncertainties remain regarding the appropriate patient selection and the duration of the drugs' effectiveness.

Following the news, Eli Lilly and Co. stock rose over $2 to $823.99 on Friday morning.