On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD). The product was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in May 2024.
Earlier this month, Eisai announced that it had received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi®.
Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Hong Kong and Israel, and the UAE. Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. In October 2024, Australia’s TGA rejected Leqembi® following safety and efficacy concerns.