FDA Approves Celgene’s REBLOZYL® for the Treatment of Anemia

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The U.S. Food and Drug Administration FDA approves Celgene’s REBLOZYL® (luspatercept-aamt) for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

What is Beta-thalassemia: Beta-thalassemia is a blood disorder that reduces the body’s production of hemoglobin. Low levels of hemoglobin lead to a shortage of mature red blood cells and a lack of oxygen in the body. People with beta-thalassemia have anemia, which can cause paleness, weakness, fatigue, and more serious complications.

What is REBLOZYL®: REBLOZYL is a first-in-class erythroid maturation agent that promotes late-stage red blood cell maturation in animal models. Celgene and Acceleron are jointly developing REBLOZYL as part of a global collaboration. It is the first and only FDA approves Celgene’s erythroid maturation agent, representing a new class of therapy for these patients.

Celgene’s 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: Celgene’s REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Today’s approval of Reblozyl is an important milestone for a majority of patients with myelodysplastic syndromes who have limited treatment options to address anemia associated with their disease. It also demonstrates our continued commitment to develop innovative products that improve the lives of patients living with serious diseases,” said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. “We are looking forward to making Reblozyl immediately available for this patient population.”

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