Whippany, NJ, March 17, 2016 – The U.S. Food and Drug Administration has approved Bayer’s KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which supported the approval of KOVALTRY for routine prophylaxis to reduce the frequency of bleeding episodes. KOVALTRY can be used two or three times per week in adolescents and adults, and two or three times per week or every other day in children.
“In the LEOPOLD trials, KOVALTRY reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis,” said Sanjay P. Ahuja, MD, LEOPOLD investigator and Director, Hemostasis & Thrombosis Center at University Hospitals Rainbow Babies & Children’s Hospital and Associate Professor of Pediatrics at Case Western Reserve University School of Medicine in Cleveland, Ohio. “KOVALTRY may offer appropriate patients a twice-weekly prophylaxis dosing option.”