(Bloomberg) – Kisunla, the Alzheimer’s virus, failed to gain support from European regulators, who said the benefits do not outweigh the risks of potential fatal bleeding in the brain.
Lilly tried to clear the drug to Alzheimer’s disease. The recommendation of the European Medicines Agency’s Drug Advisory Committee is in the final decision of the European Commission. Li said it would seek another review in a statement, calling the opinion “disappointing.”
Thumb down is Lilly’s setback, who competes with Eisai Co. and partner Biogen Inc. in the global market for Alzheimer’s treatment. Sales of such drugs could increase to $13 billion by 2030 from $250 million last year, according to Bloomberg Intelligence.
The EMA People Using Drugs Committee cited a side effect called ARIA that involves the potential of swelling and cerebral hemorrhage. The committee noted that people who received medication died.
Eli Lilly said it still wants to bring its medication to European patients, adding that it is confident in its safety and effectiveness.
Stocks rose 0.9% at 11:41 a.m. in New York.
The committee supports similar drugs from Eisai and Biogen, although their use is limited to patients with lower risk of dangerous side effects, such as brain swelling. The drug Leqembi also has a rocky road in Europe: the group supported the limited patient group of the drug after the initial advisory committee rejection. It confirmed that the decision was made earlier this year after further security reviews.
“We think that given the higher ARIA incidence, this may reverse CHMP’s opinion on Kisunla, but does put this probability lower than that of Leqembi,” William Blair analyst Myles Minter wrote in a note to clients. “So, we think there is a real risk here that Kisunla may not achieve this on the EU line.”
Both Leqembi and Kisunla are infusions that remove toxic amyloid from the brain, although they only moderately reduce the disease. They approved early Alzheimer’s disease patients in the United States – a minority of patients with a small population.
Lilly has previously received Kisunla’s approval in the United States, Japan and the United Kingdom. It has the potential convenience advantage because it is injected monthly, while Leqembi is given every other week.
– Assistance with Sonja Wind.
(Updated with analyst comments in paragraph 8.)
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