December 23, 2022
Eisai initiated data submission for BLA of lecanemab in China for Alzheimer's
Eisai and Biogen announced that they have initiated submitting data for Biologics License Application (BLA) in China for Alzheimer's disease (AD).
The drug is submitted under category 1 to China's National Medical Products Administration (NMPA). Medicines not approved in other countries and innovative are considered under category 1.
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The drug is approved based on the data from the Phase II clinical trial (Study 201), a multicenter, double-blind, placebo-controlled trial. It recruited 854 patients, in which lecanemab was compared versus placebo. The co-primary endpoints are Alzheimer's Disease Composite Score (ADCOMS) at 12 months and adverse events. At 12 months, with lecanemab 10mg/kg biweekly (ED90), there was a 64% probability of being better than placebo with 25% less decline on ADCOMS. At 18 months, the probability was 76%. However, the primary endpoint was not met.
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Eisai announced that it would submit additional data from the Clarity AD study, as suggested by the NMPA.
Lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, was developed in collaboration between Biogen and Eisai. It received Breakthrough Therapy and Fast Track designations from the United States Food and Drug Administration.