REBLOZYL® is the commercial brand name of Luspatercept for Injection, a recombinant fusion protein. It binds to select transforming growth factor-beta superfamily ligands, enhances late-stage erythroid maturation and reduces ineffective erythropoiesis.
Main Indications
Treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions;
Treatment of anemia in adult patients with myelodysplastic syndromes with ring sideroblasts (MDS-RS) who need red blood cell transfusions.
Clinical Research
The pivotal BELIEVE phase III trial demonstrated that luspatercept significantly reduced transfusion burden in adults with beta-thalassemia;
The MEDALIST phase III study showed durable transfusion independence in lower-risk MDS-RS patients;
Chinese registration study verified efficacy and a manageable safety profile for local transfusion-dependent patients.
Common Side Effects
Severe but important risks: Thromboembolic events, hypertension, severe hypersensitivity reactions;
Common mild adverse reactions: Headache, bone pain, arthralgia, fatigue, diarrhea, nausea, dizziness and injection-site reactions.
Approval Status in China
Original drug REBLOZYL® (Luspatercept for Injection) was granted conditional marketing approval in China in 2022. It is currently a prescription erythroid maturation agent.
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