CSL Behring announced that Afstyla (antihemophilic factor VIII [recombinant], single chain) is now available for children and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding. It was initially approved by the Food and Drug Administration (FDA) in May 2016.
Afstyla is the first single-chain product for hemophilia A that allows for 2–3 times weekly dosing. Activated Afstyla has an amino acid sequence identical to natural factor VIII. Afstyla was designed for greater molecular stability and long duration of action. It utilizes a covalent bond that forms a single polypeptide-chain, to improve the stability of factor VIII and lengthen factor VIII activity.
The AFFINITY clinical development program demonstrated that patients who had prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate (AsBR) of 0.00. Afstyla was also associated with a strong safety profile with no inhibitors observed.
Afstyla is available as 250 International Units (IU), 500 IU, 1000 IU, 2000 IU, and 3000 IU vial sizes.
For more information call (866) 915-6958 or visit Afstyla.com.