TGA approves novel recombinant hemophilia A treatment Afstyla

20 April 2017

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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