Posted by Michael Wonder on 07 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to U.S. FDA
5 April 2019 - Submission includes both myelodysplastic syndromes and beta-thalassemia indications.
Celgene Corporation and Acceleron Pharma today announced that Celgene has submitted a biologics license application for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes 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 submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.
