Posted by Michael Wonder on 28 Feb 2018
European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors
27 February 2018 - First new medicine in over 20 years to treat people with haemophilia A with inhibitors in Europe.
Roche today announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups.
The approval is based on two of the largest pivotal clinical studies in people with haemophilia A with inhibitors, in which Hemlibra demonstrated superior efficacy compared to prior treatment with bypassing agents as prophylaxis or on-demand.
