(Bloomberg) — Eli Lilly & Co.’s Alzheimer’s disease drug Kisunla failed to get the backing of European regulators, who said its benefits don’t outweigh the risk of potentially fatal bleeding in the brain.
Lilly had sought to get the drug cleared for early Alzheimer’s disease. The recommendation Friday from the European Medicines Agency’s drug advisory committee is pending a final decision by the European Commission. Lilly said it will seek another review, calling the opinion “disappointing” in a statement.
The thumbs-down is a setback for Lilly, which is competing with Eisai Co. and partner Biogen Inc. in a global market for Alzheimer’s treatments. Sales of such drugs could surge to $13 billion by 2030 from about $250 million last year, according to Bloomberg Intelligence.
The EMA’s Committee for Medicinal Products for Human Use cited a side effect known as Aria, which involves swelling and the potential for bleeding in the brain. The committee noted three deaths of people treated with the medicine.
Lilly said it still hopes to bring its drug to European patients, adding that it’s confident in its safety and effectiveness.
The shares rose 0.9% at 11:41 a.m. in New York.
The committee has backed a similar medicine from Eisai and Biogen, though its use was limited to patients at lower risk for dangerous side effects such as brain swelling. That drug, Leqembi, also had a rocky path in Europe: after an initial advisory committee rejection, the panel supported the drug for a limited patient group. It confirmed that decision earlier this year after further safety review.
“We see potential for an eventual reversal of the CHMP opinion for Kisunla, but do view the probability as materially lower than that of Leqembi given the higher ARIA incidence,” William Blair analyst Myles Minter wrote in a note to clients. “Accordingly, we believe that there is real risk here that Kisunla may not make it over the line in the EU.”
Both Leqembi and Kisunla are infusions that remove toxic amyloid from the brain, though they only modestly slow the disease. They are approved in the US for people with early-stage Alzheimer’s — a minority of the total patient population.
Lilly previously secured approval for Kisunla in the US, Japan and the UK. It has a potential convenience advantage because it’s infused monthly, while Leqembi is given every other week.
–With assistance from Sonja Wind.
(Updates with analyst comment in eighth paragraph.)
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