CSL Behring's Afstyla gains FDA approval

The US Food and Drug Administration has approved Afstyla (antihemophilic Factor [recombinant], single chain), a novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A from CSL Behring, a subsidiary of Australia’ CSL Limited (ASX: CSL)..

Afstyla is indicated in adults and children with hemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding. Afstyla is expected to be available in the USA early this summer, the company said.

"For 100 years, CSL has focused on researching and developing innovative therapies that meet the treatment challenges patients face,” said Andrew Cuthbertson, chief scientific officer and Director of R&D, CSL Limited. "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,” Dr Cuthbertson added.