Bristol Myers Squibb announced that the company has withdrawn a supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The Company could not appropriately address the U.S. Food and Drug Administration’s questions about the benefit-risk profile of Reblozyl in this patient population based on the current dataset from the Phase 2 BEYOND trial.
“While we will not pursue this indication in the U.S., we’re continuing to evaluate Reblozyl in a broad clinical development program to bring this important therapeutic option to more patients living with the burden of anemia,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb.
Reblozyl, a first-in-class therapeutic option, is currently approved in the United States, European Union and Canada to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes.
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