The European Commission approved Kovaltry™ antihemophilic factor (recombinant) for the treatment of hemophilia A in patients of all ages. The drug is an unmodified full-length recombinant factor VIII product.
The approval was based on results from the Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease (LEOPOLD) clinical trials, which were carried out in more than 200 children and adults with severe hemophilia A from 60 sites in 25 countries worldwide. In the LEOPOLD trials, the drug demonstrated control of and protection from bleeds when used prophylactically two to three times per week. The drug’s parent product is administered three times a week, so it offers a slight dosing advantage and flexibility.
The drug’s manufacturer is also pursuing regulatory approval in the United States and Canada.
Source: Bayer press release, February 23, 2016.