FDA Accepts BLA for Luspatercept in MDS, Grants Priority Review in Beta-Thalassemia

June 5, 2019 – The FDA has accepted a biologics license application (BLA) for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for adult patients with beta-thalassemia-associated anemia who require RBC transfusions. Moreover, the agency granted a priority … (leggi tutto)