CSL Behring recently announced that Afstyla -- CSL’s novel long-lasting recombinant factor VIII single-chain therapy, developed to treat adults and children who have hemophilia A -- has been approved by Health Canada.
Afstyla is the first and only single-chain product developed to treat hemophilia A that gives patients long-term protection from bleeds specifically. Such protection requires dosing up to two to three times each week.
"Health Canada approval of Afstyla, an innovative and effective hemophilia A therapy, further demonstrates CSL Behring’s dedication and century-long promise to develop and deliver novel treatments that have the potential to improve patients’ lives," CSL Limited Chief Scientific Officer and Director of Research and Development Dr. Andrew Cuthbertson said. "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 hemophilia A."
The patients taking part in the Afstyla clinical trials who underwent prophylaxis with the drug demonstrated a median annualized spontaneous bleeding rate (AsBR) of zero.
Afstyla, once it has been activated, is equivalent to natural factor VIII. The results of the trial also showed a strong safety profile for Afstyla.
