FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors
Basel, 17 April 2018 FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison Roche (SIX: RO, ROG;... Read more