EU Rejects Lilly’s Alzheimer’s Drug Kisunla, Following Identical Path as Rival Leqembi

Eli Lilly’s Alzheimer’s drug Kisunla has acquired a damaging opinion from the European Union’s drug analysis board. In the meantime, rivals Biogen and Eisai are nonetheless preventing for market entry for rival med Leqembi.

The EU’s Committee for Medicinal Merchandise for Human Use (CHMP) declined Thursday to advocate the monoclonal antibody for approval. The choice was primarily based totally on security considerations relating to the drug, which CHMP stated weren’t outweighed by the potential advantages of therapy.

Lilly has 15 days to ask for a re-examination of the opinion. In a assertion launched Friday, the corporate stated it will accomplish that.

CHMP pointed to the danger of amyloid-related imaging abnormalities (ARIA), a aspect impact of amyloid-targeting remedies that may sign swelling and bleeding within the mind. In information submitted to help Lilly’s utility, ARIA occurred in 36.8% of sufferers taking Kisunla, in comparison with 14.9% of sufferers who acquired placebo. Whereas most ARIA occurrences don’t trigger signs, 1.6% of sufferers did expertise “severe ARIA occasions,” and three sufferers with ARIA died.

In a regular score scale that scores Alzheimer’s illness development, Kisunla confirmed modest enhancements versus placebo, in each sufferers with and with out ApoE4 genes, a threat issue for Alzheimer’s.

Lilly’s fundamental competitor in Alzheimer’s, Biogen and Eisai, have equally struggled to get rival molecule Leqembi authorised in Europe. In July 2024, Leqembi did not safe advice for approval from CHMP, however the corporations requested for a re-examination. In November 2024, CHMP reversed course and backed approval for Leqembi, however solely in sufferers with one or no copies of the ApoE4 gene. In January 2025, nevertheless, the complete European Fee requested the CHMP to rethink primarily based on new security information. Earlier this month, CHMP reiterated its optimistic stance on Leqembi.

In a word to buyers Friday, William Blair analysts stated they “view the CHMP’s damaging opinion on Kisunla as unsurprising, given the preliminary damaging opinion for Leqembi.” The analysts additionally wrote that reexaminations end in CHMP reversing itself about 25% of the time, together with in Leqembi’s case. Nevertheless, the analysts concluded that “there may be actual threat right here that Kisunla might not make it over the road within the EU,” given the charges of ARIA reported in Lilly’s information.

Kisunla acquired FDA approval within the U.S. in July 2024. In Section III trials used to help that approval, ARIA with microhemorrhages occurred in about 31.4% of sufferers. In October 2024, Lilly unveiled new Section IIIb information exhibiting that whereas it couldn’t get rid of the adversarial occasion, modified dosing regimens may decrease the charges of ARIA and mind swelling. Lilly stated it will use that information to use for an up to date label.

Uptake of each Leqembi and Kisunla has been gradual as physicians and well being techniques regulate to the brand new therapy paradigm. Gross sales figures reported by Jefferies in February 2025 confirmed that Leqembi’s U.S gross sales had been primarily flat with about $18.9 million for the earlier month, whereas Kisunla bought $4.7 million for a similar time interval, a soar from $3.2 million.