On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi® (lecanemab) for use in treating patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The positive CHMP opinion follows Eisai’s request for re-examination of a prior negative opinion issued by the CHMP in July 2024.
Leqembi® has previously been approved for MCI and Early Alzheimer’s disease in the UK (August 2024), the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. In October 2024, Australia’s TGA decided against registering Leqembi® for these indications due to safety and efficacy concerns.