European Authority Denies Lilly's Alzheimer’s Drug Due to Fatal Risks

Eli Lilly’s Alzheimer’s treatment, Kisunla, has encountered a significant hurdle as it failed to gain endorsement from the European Medicines Agency (EMA) due to concerns over severe side effects and related fatalities. The agency’s Committee for Medicinal Products for Human Use (CHMP) advised the European Commission to decline approval for donanemab, marketed as Kisunla, citing that its advantages are overshadowed by the risks of brain swelling and bleeding, known as amyloid-related imaging abnormalities (ARIA).

This recommendation from the CHMP reflects ongoing skepticism towards anti-amyloid therapies in Europe. It comes at a time when CHMP recently approved Eisai and Biogen’s medication, Leqembi, after initially rejecting it over safety concerns earlier in the year. The agency had also turned down Biogen’s Aduhelm in 2021, prompting the company to retract its application the following year. Although the European Commission holds the ultimate authority on new drug authorizations, it typically aligns with CHMP's guidance.

CHMP’s cautious stance on Alzheimer’s treatments implicates the potential emergence of ARIAs. According to William Blair analysts, Kisunla exhibits higher ARIA rates in comparison to Leqembi. Despite these concerns, both Aduhelm and Leqembi have been approved by the FDA, and Lilly managed to secure U.S. approval for Kisunla last July.

The CHMP reported that ARIAs were observed in 36.8% of patients treated with Kisunla in contrast to 14.9% in the placebo group, with these side effects leading to the deaths of three patients. Eli Lilly expressed its disappointment with the CHMP’s verdict and plans to request a re-evaluation from the agency. The company has a 15-day window to apply for a review process. Analysts from GlobalData project that Kisunla could generate approximately $2 billion in worldwide sales by 2030.

Lilly’s application to the CHMP was supported by data from a Phase 3 trial named TRAILBLAZER-ALZ 2, which involved 1,736 participants. This data has also been instrumental in securing approvals in other countries, including the UK, Japan, and China.

Kisunla is administered to patients via an infusion drip every four weeks. It comprises a monoclonal antibody designed to bind to plaques that develop in the brains of individuals afflicted with Alzheimer’s disease.