CHMP recommends approval of Reblozyl for transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes and transfusion-dependent anemia associated with beta thalassemia.- BMS + Acceleron

-Bristol Myers Squibb and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of: 1.Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.2. Adult patients with transfusion-dependent anemia associated with beta thalassemia.

This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Reblozyl would be the first erythroid maturation agent approved in the EU, representing a new class of therapy for eligible patients. The safety and efficacy results provided in the application are from the pivotal Phase III MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.