TGA approves novel recombinant hemophilia A treatment Afstyla
The Australian Therapeutic Goods Administration (TGA) has approved Afstyla (lonoctocog alfa) a recombinant single chain coagulation factor VIII (rFVIIISingleChain) in patients with hemophilia A (congenital factor VIII deficiency) from CSL Behring, a unit of Australia’s blood plasma and vaccines specialist CSL Limited (ASX: CSL).
Afstyla, which was approved last year in the USA and Europe, is indicated in Australia for all patients with hemophilia A for:
- routine prophylaxis to prevent or reduce the frequency of bleeding episodes;
- control and prevention of bleeding episodes; and
- perioperative management (surgical prophylaxis).
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