Bayer's Kogenate FS receives FDA approval

WHIPPANY, N.J. — Bayer HealthCare on Monday announced that the Food and Drug Administration approved the company's new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.



The approval was based on data from the SPINART (Secondary Prophylaxis in Adults, a Randomized Trial) study: 84 patients ages 15 years to 50 years were randomized to receive either prophylaxis (25-IU/kg three times per week) or on-demand treatment. The results were published in the Journal of Thrombosis and Haemostasis.



"In Bayer's SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment," said Marilyn Manco-Johnson, M.D., principal investigator of the study and director of the Mountain States Regional Hemophilia and Thrombosis Center at University of Colorado at Denver and Health Sciences Center. "Such clinical information can help healthcare professionals provide appropriate treatment advice to their patients."



Kogenate FS antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly, the company said. It also noted that the drug is not used to treat von Willebrand disease.