Luspatercept is filed at EMA for myelodysplastic syndromes and beta-thalassemia-associated anemia

Celgene Corporation and Acceleron Pharma Inc.have announced that Celgene has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts, require red blood cell (RBC) transfusions and have received or are not eligible for erythropoiesis-stimulating agents, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. Luspatercept is an investigational erythroid maturation agent that regulates late-stage red blood cell maturation. The safety and efficacy results provided in the application are from the pivotal phase 3 studies MEDALIST and BELIEVE, evaluating the ability of luspatercept to effectively address anemia associated with MDS and beta-thalassemia, respectively.