Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. Reblozyl is being developed and commercialized through a global collaboration with Merck & Co., Inc., known as MSD outside the United States and Canada, following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021.
A written response to an information request was determined by the FDA to constitute a major amendment; therefore the Agency has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to provide time for a full review of the submission. The sBLA was based on safety and efficacy results from the pivotal Phase 2 BEYOND study evaluating Reblozyl plus best supportive care in adults with NTD beta thalassemia. There is an application (Type II variation) also under review by the European Medicines Agency.
Reblozyl, a first-in-class therapeutic option, is currently approved in the United States and European Union to address transfusion-dependent anemia-associated beta-thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent (ESA) and requiring red blood cell transfusions.
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