Posted by Michael Wonder on 28 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept marketing authorisation application to the EMA for MDS and beta-thalassemia
26 April 2019 - Submission to EMA follows biologics licensing application submission to U.S. FDA earlier this month.
Celgene and Acceleron Pharma today announced that Celgene has submitted a marketing authorisation application to the 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.
