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# Bristol Myers Withdraws sBLA for Reblozyl
- URL: https://www.fdaweb.com/bristol-myers-withdraws-sbla-for-reblozyl/
- Published: 2022-06-06T12:00:00.000Z
- Updated: 2026-09-14T17:47:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151982

Bristol Myers Squibb has withdrawn a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The company said it could not appropriately address FDA’s questions about the benefit-risk profile of Reblozyl in the patient population based on the current dataset from its 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,” the company said. Reblozyl is currently approved for treating transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes.