CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug

Published: 2025-03-28 08:33:29 ET LLY

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.

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

(END) Dow Jones Newswires

03-28-25 0832ET