Eisai initiates rolling Biologics License Application to US FDA for Leqembi

  BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai announced today that they have initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. In the US, Leqembi 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).

Leqembi is approved for biweekly intravenous (IV) treatment, which is normally done at medical facilities. Subcutaneous administration with an autoinjector simplifies home treatment and the injection process requires less time than the IV formulation. This makes the treatment easier for patients and their care partners and may reduce the need for hospital visits and nursing care compared to IV administration, in addition to being more convenient for patients to continue the treatment.

Alzheimer's disease is an ongoing neurotoxic process that begins before and continues after amyloid-beta (Aβ) plaque deposition, which is a hallmark of the disease. Data suggests that early and continued treatment may prolong the benefit even after Aβ plaque is cleared from the brain. If approved by the FDA, patients who have completed the biweekly IV initiation phase could transfer to the subcutaneous autoinjector 360 mg weekly maintenance regimen, currently under review. This would maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils^[i] which can continue to cause neuronal injury even after the Aβ plaque has been cleared from the brain. The BLA is based on data from the Phase 3 Clarity AD open-label extension (OLE) study, and modeling of observed data.

Leqembi is now approved in the U.S., Japan and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore and Switzerland. In March 2024, Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for less frequent monthly IV maintenance dosing of Leqembi.

Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

https://www.biospace.com/article/releases/eisai-initiates-rolling-biologics-license-application-to-us-fda-for-leqembi-lecanemab-irmb-for-subcutaneous-maintenance-dosing/