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.

The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.

The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles.

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.