By Colin Kellaher

A key European regulatory committee has recommended against approval of Eli Lilly's Kisunla, saying the benefits of the Alzheimer's disease drug don't outweigh its risks.

The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday adopted a negative opinion on Kisunla, citing the risk of potentially fatal events due to amyloid-related imaging abnormalities, involving swelling and potential bleeding in the brain.

Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP.

The Indianapolis drugmaker said it remains confident in the safety and effectiveness of the drug and the value it can bring to patients with early symptomatic Alzheimer's.

The U.S. Food and Drug Administration last year approved Kisunla, an antibody drug given as a monthly intravenous infusion that studies show has slowed the progression of the memory-robbing disease.

The CHMP last July recommended against approval of Leqembi, the Alzheimer's drug from Biogen and Eisai, citing safety and efficacy issues.

The companies asked the panel to take another look, and the CHMP in November reversed course and recommended approval the drug for a smaller subset of patients. The European Commission, which generally follows the CHMP's advice, is conducting its decision-making process for the drug.

Analysts at Citi said the CHMP's negative opinion on Kisunla wasn't a surprise, given the panels' initial stance on Leqembi.

Citi notes that while Eli Lilly will seek a re-examination by the CHMP, only about a quarter of drugs eventually win European approval after an initial negative opinion.

The analysts said, however, that a European green light would be an upside to Eli Lilly shares, as Wall Street broadly sees Kisunla sales outside the U.S. as de minimis. Citi reiterated its buy rating and $1,190 target price on Eli Lilly shares.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 28, 2025 11:45 ET (15:45 GMT)

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