Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl (luspatercept-aamt)
Bristol-Myers Squibb Company (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that following the late-cycle review meeting on December 4, 2019, they were notified by the U.S. Food and Drug Administration (FDA) that Reblozyl (luspatercept-aamt) will not be reviewed at the Oncologic Drugs Advisory Committee (“ODAC”) meeting scheduled for December 18, 2019.
The agency has informed Bristol-Myers Squibb that the original Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for its supplemental Biologics License Application (“sBLA”) for Reblozyl will remain, without the requirement for an ODAC review.
Bristol-Myers Squibb is seeking approval of Reblozyl, an erythroid maturation agent, representing a new class of therapy, for the treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and require red blood cell (RBC) transfusions.
The agency has recently granted approval of Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions. Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Reblozyl is not approved for the treatment of MDS in any country.
About Anemia in Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of closely related, but diverse blood cancers in which mutations prevent the bone marrow stem cells from making healthy blood cells. Most patients experience severe chronic anemia due to the lack of mature RBCs. Anemia associated with MDS remains a significant area of unmet need for these patients, as current treatment options are limited, consisting primarily of medicines that stimulate the production of erythropoietin, and regular RBC transfusions. Regular RBC transfusions can disrupt and diminish a patient’s quality of life and are associated with an increased risk of iron overload, transfusion reactions and infections.
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