Health Canada approves CSL Behring’s Afstyla for the treatment of haemophilia A

CSL Behring

14 December 2016 - Afstyla is the first and only single-chain recombinant factor VIII for haemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available.

CSL Behring has announced that Health Canada has approved Afstyla [anti-haemophilic factor VIII (recombinant), single chain], its novel long-lasting recombinant factor VIII single chain therapy for adults and children with haemophilia A. 

Afstyla is the first and only single-chain product for haemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate of zero. Once activated, Afstyla is identical to natural factor VIII. Afstyla also demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis.

Afstyla is indicated in adults and children with haemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; control and prevention of bleeding episodes; and peri-operative management of bleeding (surgical prophylaxis).

Read CSL Behring press release

Michael Wonder

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Michael Wonder

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Outcome , Canada , Blood product