Reblozyl (luspatercept)

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Reblozyl is used to treat transfusion-dependent anemia in adults with beta-thalassemia, myelodysplastic syndromes (MDS), myelodysplastic syndromes with ring sideroblasts (MDS-RS), or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). It is administered as a subcutaneous injection by a healthcare provider once every 3 weeks.

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Description

Reblozyl Price

Reblozyl works by specifically targeting and blocking molecules that prevent red blood cells (RBCs) from maturing, allowing them to mature properly. This helps overcome ineffective erythropoiesis (the development of RBCs) seen in conditions such as beta-thalassemia and myelodysplastic syndromes, increasing the number of RBCs in the plasma and reducing the need for blood transfusions. Reblozyl belongs to the drug class called erythroid maturation agents.

Reblozyl (luspatercept-aamt) gained FDA approval on November 8, 2019. There is no generic or biosimilar. Approval for Reblozyl was based on the following clinical trials: Reblozyl Price

Beta Thalassemia: BELIEVE (NCT02604433). Primary endpoint: 21.4% of Reblozyl patients achieved ≥33% transfusion reduction versus 4.5% placebo (P<0.0001). Secondary endpoints showed sustained benefits at weeks 37-48 (19.6% vs 3.6%) and ≥50% reduction in 7.6% vs 1.8% patients.
Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes: MEDALIST (NCT02631070). 38% Reblozyl patients achieved ≥8 weeks of transfusion independence versus 13% placebo (P<0.001). COMMANDS (NCT03682536). Interim analysis: Primary endpoint (≥1.5g/dL hemoglobin increase plus ≥12 weeks transfusion independence): 59% luspatercept versus 31% epoetin alfa (p<0.0001)

FDA approvals and uses

Reblozyl is approved to treat:

Anemia in adults with beta-thalassemia, who need regular red blood cell (RBC) transfusions
Anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adults with very low to intermediate risk myelodysplastic syndromes (MBS) who may require regular 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.

It is not known if Reblozyl is safe and effective in children.