EU Regulators Reject Eli Lilly’s Alzheimer’s Drug Over Safety Concerns
The European Medicines Agency (EMA) has rejected Eli Lilly’s Alzheimer’s drug, Kisunla, over concerns that the risks, including serious brain swelling and bleeding, outweigh its benefits. The decision puts Eisai and Biogen’s Leqembi ahead in the race to become the first approved Alzheimer’s treatment in the EU.
Lilly plans to seek a re-examination, arguing that Kisunla could still help millions suffering from the disease. However, the EMA committee highlighted that even among patients with a lower genetic risk, the treatment still posed significant dangers, with three reported deaths linked to its use.
The rejection has reignited criticism of Europe’s slow drug approval process. Lilly’s executive vice president, Ilya Yuffa, warned that the EU’s regulatory environment is discouraging innovation, while the European Commission continues to debate its first major pharma regulation overhaul in two decades.
