Shire announced that the Food and Drug Administration (FDA) has approved Adynovate (antihemophilic factor [recombinant], PEGylated) to treat hemophilia A in pediatric patients <12 years old and for use in surgical settings for both pediatric and adult patients.
Adynovate, an extended circulating half-life recombinant Factor VIII (rFVIII), was initially approved for use in patients aged ≥12 years with hemophilia A for on-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes.
The expanded FDA approval to treat children aged <12 years was supported by data from a prospective, uncontrolled, open-label, multicenter Phase 3 study designed to evaluate the immunogenicity along with the safety and efficacy of Adynovate. The study data showed Adynovate met its primary endpoint with no previously treated children having developed inhibitory antibodies to Adynovate. Over >70% of children had zero joint bleeds with Adynovate prophylaxis and almost 40% of patients experienced no bleeds. The median overall annualized bleeding rate (ABR) among pediatric patients treated with Adynovate was 2.0 (mean ABR 3.04; range 2.21–4.19), which was comparable to those seen in the adult study.
The FDA approval to to use Adynovate in surgical settings for both pediatric and adult patients was based on interim data on an ongoing Phase 3 study of perioperative control of hemostasis among 15 patients with severe hemophilia A undergoing surgical procedures.
Adynovate is available as a lyophilized powder in single-use vials containing approximately 250 IU, 500 IU, 1000 IU, or 2000 IU.
For more information call (800) 999-1785 or visit Adynovate.com.