Reblozyl FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 29, 2023.
FDA Approved: Yes (First approved November 8, 2019)
Brand name: Reblozyl
Generic name: luspatercept-aamt
Dosage form: for Injection
Company: Bristol-Myers Squibb Company
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 use in the treatment of anemia in patients with beta thalassemia and anemia in patients with myelodysplastic syndromes.
- Reblozyl is indicated for the treatment of:
- Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
- Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may 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
Further information
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