Positive CHMP opinion for Reblozyl for adult patients with anemia-associated, non-transfusion dependent(NTD) beta thalassemia.- BMS
Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with anemia associated with non-transfusion-dependent (NTD) beta thalassemia.
The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the European Union (EU). Upon approval, this would represent the third authorized indication for Reblozyl in the EU.
The CHMP adopted a positive opinion based on results from the pivotal 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, iron-chelating agents, use of antibiotic, antiviral, and antifungal therapy, and/or nutritional support, as needed.
Reblozyl is an erythroid maturation agent approved in the EU, the United States, China and Canada to address anemia-associated, transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes, representing an important class of therapy for eligible patients.
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.
4 mins