Posted by Michael Wonder on 20 Apr 2017
Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment
19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of zero.
CSL Behring today announced that the Australian TGA has approved Afstyla [lonoctocog alfa] a recombinant single chain coagulation factor VIII (rFVIIISingleChain) in patients with haemophilia A (congenital factor VIII deficiency).
Afstyla is indicated in all patients with haemophilia A for:
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Control and prevention of bleeding episodes
- Peri-operative management (surgical prophylaxis)
Afstyla is the first and only single-chain recombinant factor VIII product to treat haemophilia A. The single chain design provides sustained protection from bleeds with a strong binding affinity to Von Willebrand factor. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate (AsBR) of zero with two to three times weekly dosing. Afstyla was demonstrated to be well tolerated with no patients discontinuing the study due to adverse events.
