Celgene, Acceleron: FDA Accepts Luspatercept License Application

U.S. Food and Drug Administration grants priority review for beta-thalassemia indication and sets target action date of December 4, 2019

U.S. Food and Drug Administration sets target action date of April 4, 2020 for myelodysplastic syndromes indication

Luspatercept EU Marketing Authorization Application also validated

Celgene Corporation (CELG) and Acceleron Pharma Inc. (XLRN) 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.

https://finance.yahoo.com/news/celgene-corporation-acceleron-pharma-announce-113000756.html