In Rare Divergence From FDA, EMA Recommends Against Leqembi Approval

A committee of the European Medicines Agency (EMA) recommended against approval of Biogen and Eisai’s Alzheimer’s disease drug Leqembi this week, marking a rare disagreement in authorization decisions between FDA and EMA and one that could have financial implications for Leqembi’s makers after they dropped U.S. marketing of an earlier Alzheimer’s treatment. The European application was submitted by Eisai, which can ask for reconsideration of the decision within 15 days. In a statement Friday (July 26), Eisai said it will...