FDA approves Afstyla (rVIII-Single Chain) to treat haemophilia A- CSL Behring

CSL has announced that the FDA has approved Afstyla [Antihaemophilic Factor (Recombinant), Single Chain], CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with haemophilia A. Afstyla is indicated in adults and children with haemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding. Afstyla is expected to be available in the US early this US summer.

Afstyla (also known as rVIII-Single Chain) for haemophilia A is CSL Behring’s recombinant single-chain factor VIII specifically designed for greater molecular stability and longer duration of action. Afstyla uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of factor VIII and provide longer-lasting factor VIII activity.

Comment:Afstyla is the first and only single-chain product for haemophilia A that is specifically designed for long-lasting protection from bleeds with twice-weekly dosing available. Regulatory agencies in Europe, Switzerland and Australia are currently reviewing CSL Behring’s license applications for Afstyla.