BMS Withdrew sBLA of Reblozyl for Non-Transfusion Dependent Beta Thalassemia

Bristol Myers Squibb (BMS) has withdrawn its supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt), its injectable erythroid maturation agent.

Currently, BMS and Acceleron Pharma’s drug is FDA-approved for the treatment of anemia in adult patients with beta thalassemia who need regular blood transfusions and for the treatment of anemia in certain adult patients with very low-to-intermediate risk myelodysplastic syndrome who did not respond to an erythropoiesis stimulating agent.

The sBLA was intended to include a possible treatment option for anemia in patients with non-transfusion dependent beta thalassemia. However, the company said it could not appropriately address the FDA’s questions about the drug’s benefit-risk profile in this patient population.

Despite its withdrawal of the sBLA, BMS still plans to evaluate Reblozyl in a broad clinical development program.