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news.The US Food and Drug Administration (FDA) has approved CSL Behring's Afstyla [Antihemophilic Factor (Recombinant) Single Chain] to treat adults and children with hemophilia A.
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Afstyla, which is anticipated to be available in the US early this US summer, is indicated for routine prophylaxis to avoid or reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding.
Afstyla is CSL Behring’s recombinant single-chain factor VIII specifically designed for better molecular stability and longer duration of action.
It uses a covalent bond that establishes one structural entity, a single polypeptide-chain, to enhance the stability of factor VIII and deliver longer-lasting factor VIII activity.
CSL chief scientific officer and director of R&D Andrew Cuthbertson said: "The approval of Afstyla, an innovative and effective haemophilia A therapy, further demonstrates CSL’s dedication to developing and delivering novel therapies that have the potential to improve patients’ lives.
"We are very excited to add this treatment to our industry-leading portfolio of coagulation therapies and look forward to the positive impact Afstyla can have on patients with haemophilia A."
CSL Behring’s license applications for Afstyla are being reviewed by regulatory agencies in Europe, Switzerland and Australia.
Haemophilia A is a congenital bleeding disorder characterized by deficient or defective factor VIII. It primarily affecting males.
The US Centers for Disease Control and Prevention estimates that the condition affects about one in 6,000 male births.