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.
Earlier this year, Bayer received approval of KOVALTRY in Europe and Canada. The company has submitted an application for approval of KOVALTRY in Japan, and plans to file for approval in other countries in the coming months.
