The European Commission has approved Roche’s Hemlibra (emicizumab) in all age groups for routine prophylaxis of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors, based on the pivotal HAVEN 3 and HAVEN 4 studies.
Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development, said: "Today's approval is a landmark moment as Hemlibra is the first new class of treatment for people with severe haemophilia A without inhibitors in nearly 20 years. Moreover, Hemlibra can effectively control bleeds while offering subcutaneous dosing once weekly, every two weeks or every four weeks. We will continue to work with EU member states, to bring this important treatment to those in need as quickly as possible."
“Roche gets EC approval for Hemlibra for severe haemophilia A without factor VIII inhibitors “
Dr Elena Santagostino, Director of the Haemophilia Unit at the Angelo Bianchi Bonomi Haemophilia and Thrombosis Centre of the Cà Granda Foundation, Maggiore Hospital Policlinico of Milan, said: "We are delighted that now people with severe haemophilia A without inhibitors in the EU will also have the opportunity to benefit from Hemlibra, which has been shown to significantly reduce bleeds compared to no prophylaxis and compared to prior factor VIII prophylaxis. We are hopeful that the three different dosing options will allow people with haemophilia A and their physicians to choose the option that's right for them, based on their lifestyle and preferences."