Eisai begins rolling submission for SC Leqembi

Japanese drugmaker Eisai (TYO: 4523) has started the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Leqembi (lecanemab-irmb) subcutaneous (SC) autoinjector for weekly maintenance dosing.

An intravenous (IV) infusion of Leqembi was approved last year for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease, and approvals have also been granted in Japan and China, with applications under review in 14 countries and regions including the European Union, the UK and India.

But Eisai and its partner Biogen (Nasdaq: BIIB) are also seeking approval for a SC version of the drug.