FDA approves Reblozyl to treat anemia associated with lower-risk myelodysplastic syndromes. BMS + Acceleron

Bristol Myers Squibb and Acceleron Pharma Inc. announced the FDA has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

The FDA approval in MDS is based on results from the pivotal Phase III MEDALIST trial and marks the second indication for Reblozyl, which received its first approval in November 2019 for the treatment of anemia in adults with beta thalassemia who require regular RBC transfusions

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