A European regulatory committee rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially dangerous risks of brain bleeding and swelling.
The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it.
The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion.
Lilly said Friday that it hopes discussions about the drug continue with the agency through re-examination. The Indianapolis drugmaker noted that Kisunla has already been approved in Japan and China, among other markets.
U.S. regulators approved Kisunla last July for mild or early cases of dementia caused by the fatal, mind-robbing disease. That came a year after they approved a similar drug, Leqembi, from Japanese drugmaker Eisai.
The drugs are the first to show a delay in cognitive decline in patients, but it amounts to a matter of months.
The European committee also said last summer that Leqembi should not receive marketing authorization due to some of the same concerns. But it reversed its decision a few months later.
Both Kisunla and Leqembi are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s — sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit.
Shares of Eli Lilly and Co. climbed more than $2 to $823.99 Friday morning.
