The US Food and Drug Administration recently approved KOVALTRY®, a recombinant factor FVIII therapy manufactured by Bayer. The product is indicated for the treatment and control of bleeding in adults and children with hemophilia A, including routine prophylaxis, to reduce the frequency of bleeding episodes.
The drug's approval was based on the successful results of a series of clinical trials called the Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease (LEOPOLD). The program was designed to evaluate the pharmacokinetics, safety, efficacy of prophylaxis, treatment of bleeds and perioperative management in adults, adolescents and children with severe hemophilia A.
“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.”
It is expected that adolescents and adults may be able to infuse twoo three times weekly. Children may be able to use KOVALTRY for prophylaxis two to three times per week or every other day. During the clinical trials, the main adverse reactions were headache, fever and an itchy rash.
Source: PRNewswire, March 17, 2016
