Eisai and Biogen announced that China’s National Medical Products Administration (NMPA) has approved a once-every-four-weeks intravenous (IV) maintenance dosing schedule for LEQEMBI (lecanemab), their Alzheimer’s treatment. The decision follows LEQEMBI’s initial approval in January 2024 for patients with early-stage Alzheimer’s disease, including those with mild cognitive impairment (MCI) or mild dementia.
LEQEMBI is a humanized monoclonal antibody that targets soluble aggregated amyloid-beta (Aβ), a protein that forms plaques in the brains of people with Alzheimer’s. The updated approval allows patients to shift from the initial dosing of 10 mg/kg every two weeks over 18 months to a maintenance regimen of the same dose once every four weeks, offering more flexibility for long-term treatment.
LEQEMBI is currently the only approved Alzheimer’s therapy that targets both amyloid plaque and Aβ protofibrils, which are believed to play key roles in the neurodegenerative process that leads to cognitive decline. By addressing these targets, LEQEMBI may also influence downstream tau pathology, another hallmark of Alzheimer’s disease.
Alzheimer’s is a progressive and irreversible disease, and the number of patients in China is growing rapidly. Eisai estimates that in 2024, about 17 million people in China had MCI or mild dementia due to Alzheimer’s, a figure expected to rise with the aging population.
Eisai leads the global development and regulatory strategy for lecanemab, while both Eisai and Biogen co-promote the drug worldwide. In China, Eisai is responsible for distribution and medical engagement through specialized representatives.