EU approves Kovaltry (recombinant Factor VIII) to treat haemophilia A.-Bayer HealthCare
Bayer has received approval from the European Commission of Kovaltry for the treatment of hemophilia A in patients of all age groups. Kovaltry is an unmodified full-length recombinant factor VIII product, that in clinical trials has demonstrated control of bleeds, and protection from bleeds in hemophilia A patients when used prophylactically two or three times per week.
The approval was based on the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) Clinical Development Program, which consisted of three multinational clinical trials designed to evaluate the pharmacokinetics, efficacy and safety of Kovaltry. The combined trials evaluated Kovaltry in more than 200 children and adults with severe hemophilia A from 60 sites and 25 countries worldwide.
Comment: Kovaltry is set to eventually replace Bayer’s marketed rFVIII (Kogenate) and has fewer injections than Kogenate. It will compete against long acting rfVIII products such as Elocate from Biogen. Kovaltry was filed at the FDA in December 2014.
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