EMA Endorses Leqembi for Alzheimer's Treatment in Restricted Population Following Reversal

The European Medicines Agency (EMA) has revised its stance and now supports the use of Leqembi, a treatment developed by Eisai and Biogen for Alzheimer's disease, specifically for patients with mild cognitive impairment or mild dementia who have either one or no copies of the ApoE4 gene[1]. This revised decision comes after an appeal from Eisai, during which they presented clinical data indicating a reduced risk of amyloid-related imaging abnormalities (ARIA) in the restricted patient group[2]. The EMA's reversal aligns it more closely with other regulatory bodies like the UK's, although it remains more restrictive than the U.S. FDA's broader approval criteria[1][2].