Posted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically significant and clinically meaningful improvement compared to an erythropoiesis-stimulating agent in patients with very low/low/intermediate-risk MDS.
Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application and the EMA has validated the type II variation application for Reblozyl (luspatercept-aamt), a first-in-class treatment option, to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.
