Posted by Michael Wonder on 04 Jun 2019
Celgene Corporation and Acceleron Pharma announce U.S. FDA accepts luspatercept biologics license application in myelodysplastic syndromes and beta-thalassemia
4 June 2019 - U.S. FDA grants priority review for beta-thalassemia indication and sets target action date of 4 December 2019.
Celgene Corporation and Acceleron Pharma today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, 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, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.
The FDA has granted Priority Review to this BLA for the evaluation of the beta-thalassemia indication and set a Prescription Drug User Fee Act (PDUFA), or target action, date of December 4, 2019. The FDA has also set a PDUFA date of April 4, 2020 for the evaluation of the MDS indication.
