Bristol Myers Squibb announced that the European Commission (EC) has expanded approval of Reblozyl®(luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). This approval of Reblozyl covers all EU member states. The approval is based on the pivotal Phase 3 COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in the study?s primary endpoint of concurrent red blood cell transfusion independence and hemoglobin increase.

Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population. Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.