Roche reports EC approves label expansion of Hemlibra

Roche announced that the European Commission approved the expansion of the Hemlibra European Union marketing authorization. The label will now include the routine prophylaxis of bleeding episodes in people with hemophilia A without factor VIII inhibitors, who have moderate disease with a severe bleeding phenotype. "We welcome the European Commission’s decision to approve Hemlibra also for people with moderate hemophilia A in the EU, since even moderate disease can produce bleeds that cause irreversible joint damage and impact quality of life," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.