European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Lilly will request a CHMP re-examination of its Alzheimer's disease drug Kisunla (Shutterstock)
Key Takeaways
  • The EMA has declined to recommend Eli Lilly’s beta-amyloid targeting antibody Kisunla for treating Alzheimer’s disease.
  • The agency said the product’s benefits did not outweigh the risks of potentially fatal events.
  • Lilly says it will request a re-examination.

Eli Lilly has suffered a major setback after the European Medicines Agency recommended against approving the company’s Alzheimer’s disease drug, Kisunla (donanemab), for use in the EU

The EMA’s human medicines committee, the CHMP, rejected Kisunla because it did not believe that the benefits of the drug were large enough to outweigh the risk of potentially fatal

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