On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. The sBLA for monthly Leqembi® IV maintenance dosing had been accepted by the FDA in June 2024.
This news comes two weeks after the US FDA accepted Eisai/Biogen’s Biologics Licence Application for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indication.
Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE. In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland. In October 2024, Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® due to safety and efficacy concerns.