Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Kovaltry (antihemophilic factor VIII [recombinant]) for the treatment of hemophilia A in adults and children. 

Kovaltry is an unmodified, full-length factor VIII compound that can be administered 2 or 3 times per week in adolescents and adults, and 2 or 3 times per week or every other day in children. It temporarily replaces the missing clotting factor VIII that is necessary for effective homeostasis. 

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The FDA approval was based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials that supported its use as routine prophylaxis to reduce frequency of bleeding episodes. The program evaluated Kovaltry’s pharmacokinetics, safety, and efficacy of prophylaxis, treatment of bleeds, and perioperative management in adults, adolescents, and children with severe hemophilia A. 

LEOPOLD 1 and LEOPOLD 2 were multi-center, open-label, cross-over, uncontrolled randomized studies in patients aged ≥12 to <65 years; its primary efficacy variable was annualized bleeding rate. LEOPOLD Kids Part A was a multi-center, open-label, uncontrolled study in patients aged ≤12 years; its primary efficacy variable was annualized number of total bleeds during routine prophylaxis that occurred within 48 hours of previous prophylaxis infusion. 

Kovaltry is supplied as a lyophilized powder in single-use vials with a vial adapter and diluent. It is available as 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU nominal strengths.  

For more information call (800) 288-8371 or visit