Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China

Core Viewpoint - Eisai and Biogen announced the acceptance of the Biologics License Application (BLA) for the subcutaneous formulation of LEQEMBI (lecanemab) by the National Medical Products Administration (NMPA) in China, which could allow for at-home administration of the treatment for Alzheimer's disease [1][2]. Group 1: Product Details - The subcutaneous autoinjector (SC-AI) formulation of LEQEMBI allows for a 500 mg dose (two 250 mg injections) to be administered weekly at home, providing an alternative to the current intravenous (IV) administration [2]. - Each autoinjector delivers a 250 mg injection in approximately 15 seconds, potentially reducing healthcare resources associated with IV dosing [2]. - LEQEMBI targets protofibrils of amyloid beta (Aβ), which are believed to contribute to cognitive decline in Alzheimer's disease [4]. Group 2: Market Potential - Eisai estimates that there were 17 million patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in China in 2024, a number expected to rise with the aging population [3]. - The approval of the SC-AI formulation could expand treatment options for patients and caregivers, facilitating easier access to therapy [2]. Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for LEQEMBI, with both Eisai and Biogen co-commercializing and co-promoting the product [3][8]. - The collaboration between Eisai and BioArctic, initiated in 2005, has been crucial for the development and commercialization of lecanemab [9]. Group 4: Regulatory Status - LEQEMBI has been approved in 52 countries and is under regulatory review in 8 countries, with recent approvals including subcutaneous maintenance dosing in the U.S. and inclusion in China's "Commercial Insurance Innovative Drug List" [6].