The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address a broader patient population.
This decision follows positive results from a Phase III study, which met its primary endpoint of achieving concurrent red blood cell transfusion independence and hemoglobin increase, demonstrating superior efficacy compared to the erythropoiesis-stimulating agent epoetin. The new indication has also received approval in the markets of Japan and the United States.- Flcube.com
