Octapharma USA announced that the Food and Drug Administration (FDA) has approved Nuwiq (antihemophilic factor [recombinant]) for the treatment of hemophilia A in children aged ≥2 and adults.

Nuwiq is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes. It is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, for the treatment of patients with hemophilia A, a congenital FVIII deficiency.

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The FDA approval was based on several global open-label clinical trials of previously treated pediatric and adult patients with hemophilia A. In a study of 32 adults, overall prophylactic efficacy of Nuwiq for spontaneous bleeds was rated as excellent or good in 92% of patients and in a study of 59 children, prophylactic efficacy for spontaneous bleeds was rated as excellent or good in 97% of patients. For hemophilia A patients receiving Nuwiq prophylaxis, the annualized bleeding rates (ABR) were reduced 96% for adults and 93% for children compared to on-demand treatment. Overall efficacy in surgical prophylaxis was rated excellent or good in 97% of procedures using Nuwiq.

Nuwiq is supplied in packages with a single-use vial containing nominally 250, 500, 1000, or 2000 IU of Factor VIII potency, a pre-filled syringe with 2.5mL solvent, a vial adapter, a butterfly needle, and two alcohol swabs. It is expected to launch in early 2016.

For more information visit OctaPharma.com.