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# Celgene Files BLA for Erythroid Maturation Agent
- URL: https://www.fdaweb.com/celgene-files-bla-for-erythroid-maturation-agent/
- Published: 2019-04-05T12:00:00.000Z
- Updated: 2026-09-15T01:18:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143802

Celgene has submitted a BLA for luspatercept, an erythroid maturation agent for treating adult patients with very low to intermediate risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions. It is also seeking approval for treating adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The BLA is based on data from the Phase 3 studies MEDALIST and BELIEVE. Luspatercept is described by Celgene as a first-in-class erythroid maturation agent that regulates late-stage red blood cell maturation. It was jointly developed with Acceleron Pharma.