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.

European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer and then reconsidered it. The infused treatment from Japanese drugmaker Eisai and Biogen received approval for patients in early stages of the fatal,

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi behind them and focus on the drug's launch in the region. | The drug has hit several roadblocks in its European regulatory journey after its first rejection last July kicked off a stint of back-and-forth decisions.