On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.
This acceptance follows the completion of Eisai’s fast-tracked BLA in October 2024. 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) rejected Leqembi® following safety and efficacy concerns. The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly Leqembi® IV maintenance dosing in June 2024.