Celgene, Acceleron announce BLA submission for luspatercept to FDA

Celgene (CELG) and Acceleron Pharma (XLRN) announced that Celgene has submitted a Biologics License Application, or BLA, 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, or 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.
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