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Reblozyl FDA Approval History

Last updated by Judith Stewart, BPharm on June 14, 2021.

FDA Approved: Yes (First approved November 8, 2019)
Brand name: Reblozyl
Generic name: luspatercept-aamt
Dosage form: for Injection
Company: Celgene Corporation
Treatment for: Anemia in Beta-Thalassemia; Anemia in Lower-Risk Myelodysplastic Syndromes

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for the treatment of:

  • Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
  • Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
  • Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Development Timeline for Reblozyl

DateArticle
Apr  3, 2020Approval  FDA Approves Reblozyl (luspatercept-aamt) to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)
Nov  9, 2019Approval  FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions
Jun  4, 2019Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia
Apr  5, 2019Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
Dec  2, 2018Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 MEDALIST Trial Evaluating Luspatercept in Patients with Myelodysplastic Syndromes at the ASH 2018 Plenary Session
Dec  1, 2018Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 BELIEVE Trial Evaluating Luspatercept in Adult Patients with Beta-Thalassemia at ASH 2018
Jul  9, 2018Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE' Study in Adults with Transfusion-Dependent Beta-Thalassemia
Jun 28, 2018Celgene and Acceleron Announce Luspatercept Achieved Primary and Key Secondary Endpoints in Phase III ‘MEDALIST’ Study in Patients with Low-to-Intermediate Risk Myelodysplastic Syndromes

Further information

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