FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License Application, sBLA, for once every four weeks lecanemab-irmb intravenous, IV, maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease, AD, in patients with mild cognitive impairment, MCI, or mild dementia stage of disease in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.