EMA’s CHMP snubs donanemab, even for APOE4 non-carriers

Due to safety concerns, EMA’s CHMP has recommended against approval of Kisunla donanemab to treat early Alzheimer’s disease, even in patients with no copies of the risk allele APOE4. The news comes one month after the committee reaffirmed a positive opinion for competing anti-amyloid therapy Leqembi in patients with zero or one copy of APOE4.

In its Phase III study, Kisunla from Eli Lilly and Co. (NYSE:LLY) led to amyloid‑related imaging abnormalities (ARIA) in a larger fraction of patients than Leqembi lecanemab did in its Phase III trial. Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) co-commercialize Leqembi...