Kovaltry is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) for adults, adolescents and children of all ages.
*The population PK model was developed based on all available FVIII measurements throughout the LEOPOLD clinical studies.
†Data are geometric means.
‡Area under the curve calculated for a dose of 50 IU/kg.
LEOPOLD, Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease; PK, pharmacokinetics; PTP, previously treated patient