CSL Behring has received approval from the US Food and Drug Administration (FDA) for the use of its recombinant factor VIII single-chain therapy, Afstyla, as a treatment for haemophilia A.
Hemophilia A is a congenital bleeding disorder that causes prolonged or spontaneous bleeding, especially into muscles, joints or internal organs.
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Said to be the first and only single-chain product for the treatment of haemophilia A, Afstyla can protect the patient from bleeds.
The drug can be administered on patients for routine prophylaxis to reduce the frequency of bleeding episodes.
Using a covalent bond that forms one structural entity and a single polypeptide-chain, Afstyla improves the stability of factor VIII to provide longer-lasting factor VIII activity.
Besides controlling bleeding episodes, Afstyla can also be used for perioperative management of bleeding in adults and children with haemophilia A.
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By GlobalDataCSL chief scientific officer Dr. 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."
The FDA approval is based on the drug’s efficacy results from Affinity clinical development programme, which involved two pivotal and one extension open-label multi-centre studies.
During the studies, adult and adolescent patients with haemophilia A were treated with Afstyla.
