Leaders at the U.S. Food and Drug Administration (FDA) recently granted approval to CSL Behring’s new Afstyla recombinant factor VIII single chain therapy, designed to treat hemophilia A.
"For 100 years, CSL has focused on researching and developing innovative therapies that meet the treatment challenges patients face,” Andrew Cuthbertson, chief scientific officer of CSL Limited, said. "The approval of Afstyla, an innovative and effective hemophilia A therapy, further demonstrates CSL’s dedication to developing and delivering novel therapies that have the potential to improve patients’ lives. 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.”
Afstyla is currently the world’s first and only treatment that is a single-chain product specifically for hemophilia A. The goal of the treatment is to offer long-lasting protection for patients who suffer from bleeds. Afstyla needs to be administered twice a week for it to be effective.
“FDA’s approval of the first recombinant single-chain therapy that offers long-lasting hemostatic efficacy provides an important new treatment option for patients and health care providers, as it has been specifically designed for increased molecular stability and duration of action,” Lisa Boggio, AFFINITY clinical development program study investigator, said. “Afstyla offers patients an opportunity for excellent efficacy with a strong safety profile and twice-weekly dosing -- potentially helping patients to fit treatment into their active lives.”
