Eli Lilly’s Alzheimer’s treatment Kisunla (donanemab) experienced a regulatory turnaround by the European Medicines Agency’s CHMP, which changed its previous negative opinion. The CHMP recommended Kisunla for approval in early Alzheimer’s patients who are ApoE4 heterozygotes or non-carriers, citing a favorable risk-benefit balance despite prior concerns over brain edema and hemorrhage risks. The acceptance marks a significant shift in the regulatory landscape for Alzheimer’s therapies in Europe and may pave the way for market entry.