The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.

Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval for Leqembi (lecanemab) for early Alzheimer’s disease.

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.