14 November 2016 - CSL today announced that the EMA's CHMP has recommended granting marketing authorisation for CSL Behring’s Afstyla [recombinant human coagulation factor VIII, single chain] for patients with haemophilia A.

Afstyla (also known as rVIII-Single Chain) for haemophilia A is CSL Behring’s recombinant single-chain factor VIII specifically designed for greater molecular stability and longer duration of action. Afstyla uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of factor VIII and provide extended factor VIII activity with the option of twice weekly dosing.

Afstyla is approved in the U.S. In addition to the European Union, regulatory agencies in markets around the world, including Switzerland and Australia, are currently reviewing CSL Behring’s marketing applications for Afstyla.

Read CSL press release