Lilly stock dips as Kisunla misses EU approval

Investing.com -- Shares of Eli Lilly and Company (NYSE:LLY) edged down 0.6% following the European Medicines Agency’s recommendation to refuse marketing authorization for Kisunla, the company’s treatment for early Alzheimer’s disease. The decision, announced on March 27, 2025, came after concerns were raised over the safety and efficacy of the medication.

The Agency’s opinion highlighted significant safety concerns regarding the frequent occurrence of amyloid-related imaging abnormalities (ARIA) in patients treated with Kisunla. ARIA, which can result in brain swelling and potential bleeding, was observed in 36.8% of Kisunla recipients versus 14.9% in the placebo group. Notably, 1.6% of those treated with Kisunla experienced serious ARIA events, with three cases leading to death.

Despite further analyses in a subgroup of patients with no copies of the ApoE4 gene, known to have a lower risk of ARIA, the side effect still occurred in 24.7% of Kisunla-treated patients compared to 12% on placebo. The study also reported a serious ARIA event that resulted in death in this subgroup.

On the efficacy front, the study showed a marginal difference in the worsening of the iADRs score between Kisunla and placebo recipients. However, the lack of long-term effectiveness data, particularly in patients without ApoE4 copies, raised additional concerns.

The EMA concluded that the potential benefits of Kisunla did not outweigh the risks, particularly the risk of potentially fatal ARIA events. This decision took into account the perspectives of patients, healthcare professionals, and experts from a scientific advisory group, who all underscored the urgent need for new Alzheimer’s treatments.

Eli Lilly Nederland B.V., the subsidiary that applied for the authorization, has the option to request a re-examination of the opinion within 15 days of receipt.

This setback for Eli Lilly comes as the pharmaceutical industry continues to face challenges in developing effective and safe treatments for Alzheimer’s, a disease that currently has few options and represents a significant unmet medical need. The refusal of Kisunla’s marketing authorization in Europe is a notable development, considering the high incidence of Alzheimer’s across the continent and the demand for innovative therapies.

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