| 2019-04-26 07:36:55|
CELG, XLRN 07:36 04/26 04/26/19
Celgene, Acceleron announces submission of luspatercept MAA to EMA
Celgene Corporation (CELG) and Acceleron Pharma (XLRN) announced that Celgene has submitted a Marketing Authorization Application to the European Medicines Agency for luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts, require red blood cell 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. Luspatercept is an investigational therapy that is not approved for any use in any country.