FDA approves antihemophilic factor VIII for hemophilia A

May 13, 2014

FDA has approved a new indication for antihemophilic factor VIII (recombinant),(Kogenate FS, Bayer), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

FDA has approved a new indication for antihemophilic factor VIII (recombinant) (Kogenate FS, Bayer), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

“Factor VIII [FVIII] is an essential blood-clotting protein produced by the body,” said FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “This protein is also known as antihemophilic factor [AHF].”

Data from the SPINART (Secondary Prophylaxis in Adults, a Randomized Trial) study demonstrated the effectiveness of antihemophilic factor VIII in treating patients with hemophilia A. The phase 3, open-label, randomized, parallel-group study involved 84 patients aged 15 years to 50 years who were randomly assigned to either prophylaxis (25 IU/kg 3 times per week) or on-demand treatment.

In the study, published in the Journal of Thrombosis and Haemostasis, patients were stratified based on target joints (presence/absence) and the number of bleeding events in the previous 6 months (≥15 vs <15 annualized bleeds). Safety and efficacy results from an analysis of the primary end point of bleeding frequency after a median 1.4-year follow-up period provided the basis for the approval. Safety objectives were also met. Adverse events were consistent with the existing safety profile for antihemophilic factor VIII.

Common adverse reactions (≥4%) seen in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions (eg, rash, pruritus), infusion-site reactions (eg, inflammation, pain), and central venous access device (CVAD) associated infections.