CSL Behring files BLA for hemophilia B agent

USA-based CSL Behring, a unit of Australia’s CSL Ltd (ASX: CSL), has submitted a biologics license application (BLA) to the US Food and Drug Administration for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).

Once approved by the FDA, rIX-FP (coagulation Factor IX [0recombinant], albumin fusion protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days.

Noting that the BLA filing is a significant milestone for the company, Andrew Cuthbertson, chief scientific officer and R&D director of CSL Ltd, said: "Our strong partnership with and commitment from the hemophilia community led us to develop rIX-FP based on novel recombinant albumin fusion technology. This technology has led to a long-acting treatment candidate that continues our legacy of improving the well-being of patients with bleeding disorders and other rare diseases."