European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer.

Biogen BIIB and partner Eisai announced that the European Commission (EC) has granted marketing authorization to Leqembi (lecanemab) for early Alzheimer’s disease (AD). The regulatory body has approved Leqembi as a treatment for adult patients with early AD who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe.

The European Commission said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for early-stage Alzheimer's disease, to be sold in the EU under strict conditions.