On 30 July 2024, Biogen and Eisai announced results from their open label extension study of Leqembi® (lecanemab) in early Alzheimer’s Disease. The data reportedly shows that three years of continuous treatment with lecanemab reduced clinical decline, demonstrating a continued clinically and personally meaningful benefit for early-stage Alzheimer’s Disease patients. Biogen and Eisai further report that dual-acting lecanemab is the only widely available early-stage treatment for Alzheimer’s Disease that supports neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain.
This follows the CHMP’s recommendation against granting marketing authorisation for Eisai’s Leqembi® (lecanemab) for Alzheimer’s disease on the basis that the observed effect of Leqembi® on delaying cognitive decline does not counterbalance the risk of serious side effects. Eisai has indicated it intends to seek review of that decision.