FDA approves Reblozyl for additional use, the important indication of MDS

The US Food and Drug Administration has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring two or more red blood cell (RBC) units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Developed by US pharma major Bristol-Myers Squibb (NYSE: BMY), Celgene (now part of B-MS under a $74 billion buy-out) and Acceleron Pharma (Nasdaq: XLRN), Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

In November last year, the drug was approved by the FDA for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. Reblozyl is under regulatory review in Europe.