Swedish research-based biopharma company BioArctic AB (Nasdaq Stockholm: BIOA B) announced on Thursday that its Japanese partner Eisai has completed the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lecanemab-irmb (US brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.

Lecanemab-irmb is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).

The BLA is based on data from the Clarity AD open-label extension study and modelling of observed data. If the application is approved by the FDA, the Leqembi autoinjector could be used to administer Leqembi at home or at medical facilities, with the injection process taking approximately 15 seconds on average.

Lecanemab-irmb is approved in the United States, Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain. The company has also submitted applications for approval of lecanemab in 10 other countries and regions, including the European Union.