Posted by Michael Wonder on 03 Apr 2020
U.S. FDA approves Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent, to treat anaemia in adults with lower-risk myelodysplastic syndromes
3 April 2020 - The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell transfusions and have failed an erythropoiesis stimulating agent.
Bristol Myers Squibb and Acceleron Pharma today announced the U.S. FDA has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent, for the treatment of anaemia 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 or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.
The FDA approval in MDS is based on results from the pivotal Phase 3 MEDALIST trial and marks the second indication for Reblozyl, which received its first approval in November 2019 for the treatment of anaemia in adults with beta thalassaemia who require regular RBC transfusions.
