On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of Early Alzheimer’s Disease from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico.
This news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024. 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 the EU, 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.