Eisai/BIIB's "loncapecad" has been approved by the FDA for the treatment of early Alzheimer's disease.

On January 26, Eisai (ESALY.US) and Biogen (BIIB.US) jointly announced that the FDA approved the supplemental Biologics License Application (sBLA) for the IV formulation of Lecanemab (brand name: Leqembi) for the maintenance treatment of patients with early Alzheimer's disease (AD) at a dose of once every 4 weeks, i.e., patients with mild cognitive impairment or mild dementia stage AD. Early AD patients need to receive Lecanemab at a dose of once every 2 weeks (Q2W) in the initial stage, followed by once every month to maintain effective drug concentrations to clear toxic protofibrils (which continue to exist even after Aβ plaques are cleared from the brain, causing neuronal damage). AD is a continuous neurotoxic process that starts before Aβ plaques deposition and continues to progress after Aβ plaques deposition. Early treatment of AD is urgent because continuous treatment in the early stage can slow down the progression of AD. The earlier the mild cognitive impairment and mild dementia caused by AD are diagnosed and treated, the greater the chances of patients benefiting.