EU grants approval of Reblozyl for anemia in non-transfusion-dependent (NTD) beta thalassemia.- BMS
Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anaemia associated with non-transfusion-dependent (NTD) beta thalassemia.
Reblozyl is currently approved in the European Union (EU), United States and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes. The centralized Marketing Authorization approves use of Reblozyl in all EU member states, as well as Norway, Iceland and Liechtenstein.
The EC approval of Reblozyl was based on results from the Phase II BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. Patients were eligible to receive best supportive care, including red blood cell transfusions and iron-chelating agents. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins