Bristol Myers Squibb announced that the FDA has approved Reblozyl® (luspatercept-aamt) to treat anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions. Reblozyl® is the first and only therapy that has demonstrated better patient outcomes compared to an ESA in MDS-related anemia.
On 1 May 2023, BMS announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application for Reblozyl® (luspatercept-aamt) to treat the above patient group.
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