EMA Endorses Eisai and Biogen's Leqembi for Select Alzheimer's Patients Amid Safety Concerns

The European Medicines Agency (EMA) has reversed its earlier stance and now endorses the approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for a restricted group of patients. This decision allows the drug to be used in those with mild cognitive impairment or mild dementia due to Alzheimer's, but importantly, only among patients with no more than one copy of the ApoE4 gene, as individuals with two copies are more susceptible to amyloid-related imaging abnormalities (ARIA), a risk involving brain swelling and microbleeding[1][2]. This recommendation comes after an appeal from Eisai proved effective, backed by new subgroup analyses showing reduced ARIA incidence in the selected patient group[2]. The EMA's decision requires continuous monitoring and a controlled access scheme, significantly aligning with the UK’s approach while differentiating from the broader U.S. approval[1].