Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food and Drug Administration (FDA) for its first-in-class drug Reblozyl (luspatercept). The drug is now approved as a first-line treatment for low- to intermediate-risk myelodysplastic syndromes (MDS)-related anemia in adults who may require regular red blood cell (RBC) transfusions. Previously, the biologic was approved for patients with MDS-related anemia who failed erythropoiesis stimulating agent (ESA) therapy, as well as for beta thalassemia-related anemia.
Phase III Trial Results and Efficacy
The FDA’s decision is based on interim results from a Phase III trial, which showed that 58.5% of individuals receiving Reblozyl achieved concurrent RBC transfusion independence and hemoglobin (Hb) increase, a rate nearly twice as high as the 31.2% observed in the placebo arm. This data underscores the potential benefits of Reblozyl as a treatment option for MDS-related anemia.
Partnership with Merck, Sharp & Dohme (MSD)
BMS is developing and commercializing Reblozyl in partnership with US compatriot Merck, Sharp & Dohme (MSD; NYSE: MRK). MSD is entitled to receive milestone and royalty payments associated with the product’s development and commercial success.-Fineline Info & Tech
