Tag Archives: Breakthrough Therapy

Roche: US FDA granted Breakthrough Therapy Designation to Hemlibra® for people with haemophilia A without factor VIII 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 BASEL, 19-Apr-2018 — /EuropaWire/ — Roche … Read the full press release

Sanofi and its subsidiary Genzyme announced that US FDA granted Breakthrough Therapy designation to olipudase alfa

Investigational Enzyme Replacement Therapy to Treat Non-Neurological Manifestations which characterize Niemann-Pick Type B PARIS, 5-6-2015 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa. … Read the full press release