Bristol Myers Squibb announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application, for Reblozyl® (luspatercept-aamt) to include treatment of anaemia (without previous use of erythropoiesis-stimulating agents in adults with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of 28 August 2023.
In August 2021, the TGA approved Reblozyl® for transfusion dependent anaemia.