Posted by Michael Wonder on 14 Mar 2019
European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
14 March 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient comparison.
Roche today announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. Hemlibra can be used in all age groups, and can also now be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors.
This approval is based on results from the pivotal HAVEN 3 and HAVEN 4 studies.
