The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on Eli Lilly's Alzheimer's disease treatment Kisunla, determining that the drug's benefits do not outweigh its potential risks. The decision, announced on Friday, represents a significant setback for the company's European commercialization plans.
The CHMP specifically cited concerns about amyloid-related imaging abnormalities (ARIA), which can cause brain swelling and potential bleeding that may lead to fatal outcomes. These safety concerns ultimately outweighed the therapeutic benefits in the committee's risk-benefit assessment.
Eli Lilly has announced it will request a re-examination of the application, expressing continued confidence in Kisunla's safety profile and therapeutic value for patients with early symptomatic Alzheimer's disease.
"We remain confident in the safety and effectiveness of the drug and the value it can bring to patients with early symptomatic Alzheimer's," the Indianapolis-based pharmaceutical company stated following the decision.
Regulatory Divergence Between US and Europe
The European rejection contrasts with the drug's regulatory success in the United States, where the Food and Drug Administration (FDA) approved Kisunla last year. Clinical studies demonstrated the antibody drug's ability to slow the progression of Alzheimer's disease when administered as a monthly intravenous infusion.
This divergence highlights the different regulatory approaches between the two regions, particularly regarding novel Alzheimer's therapies. The CHMP has shown a more conservative stance toward this class of treatments, as evidenced by its initial rejection of Biogen and Eisai's similar Alzheimer's drug Leqembi in July before later recommending approval for a narrower patient population following re-examination.
Market Implications and Analyst Perspectives
Financial analysts at Citi noted that the negative opinion was not unexpected given the CHMP's previous handling of Leqembi. They pointed out that historically only about 25% of drugs eventually secure European approval after receiving an initial negative opinion.
However, analysts also suggested that European approval would represent upside potential for Eli Lilly shares, as current Wall Street projections generally consider non-U.S. Kisunla sales to be minimal. Citi maintained its "buy" rating for Eli Lilly with a target price of $1,190.
Alzheimer's Treatment Landscape
Kisunla represents part of a new generation of antibody treatments targeting amyloid plaques in the brain, which are believed to contribute to the progression of Alzheimer's disease. These therapies have shown promise in slowing cognitive decline but have faced regulatory scrutiny due to safety concerns, particularly regarding ARIA.
Alzheimer's disease affects millions globally, with limited effective treatment options available. The disease progressively destroys memory and cognitive functions, creating a significant unmet medical need and burden on healthcare systems worldwide.
For patients with early symptomatic Alzheimer's disease, access to novel treatments remains a critical issue, with regulatory decisions significantly impacting treatment availability across different regions.
Next Steps for Kisunla in Europe
Eli Lilly's re-examination request will trigger another review process by the CHMP. While the path forward remains challenging based on historical precedent, the committee's eventual reversal on Leqembi provides some context for potential reconsideration.
The European Commission, which typically follows CHMP recommendations, will make the final decision on Kisunla's approval status in Europe following the re-examination process.
