FDA approves CSL haemophilia A drug

pharmafile | May 26, 2016 | News story | Sales and Marketing CSL, afstyla, haemophilia a, treatment 

CSL (ASX: CSL) has announced that the US Food and Drug Administration (FDA) has approved Afstyla (antihaemophilic factor [recombinant), single chain) for the treatment of haemophilia A.

The drug is a long-lasting recombinant factor VIII single-chain therapy indicated for adults and children with haemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It can also be used for on-demand treatment and control of bleeding episodes, as well as the perioperative management of bleeding.

It is expected to be made available in the US within the next few months.

Dr Andrew Cuthbertson, chief scientific officer at CSL, says: “The approval of Afstyla, an innovative and effective haemophilia 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 haemophilia A.”

Sean Murray

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