- In March 2024, Bristol Myers Squibb announced the expansion of Reblozyl’s indication in the U.S. following FDA approval for the treatment of anemia in adult patients with non-transfusion-dependent beta-thalassemia. This regulatory milestone reflects the growing clinical confidence in erythroid maturation agents beyond transfusion-dependent populations and is expected to broaden patient access, reinforcing Reblozyl's market leadership in anemia therapeutics
- In February 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Reblozyl for anemia associated with very low- to intermediate-risk MDS with ring sideroblasts in adults. This endorsement supports the expansion of erythroid maturation therapy across Europe, offering a targeted solution for patients who are ESA-refractory or have limited options
- In January 2024, Acceleron Pharma, a subsidiary of Bristol Myers Squibb, initiated Phase 3 clinical trials investigating the long-term efficacy of erythroid maturation agents in pediatric populations with transfusion-dependent thalassemia. This trial aims to address a significant unmet need in pediatric hematology and demonstrates the company’s commitment to expanding treatment to younger patient groups with chronic anemia
- In October 2023, Health Canada approved Reblozyl for the treatment of anemia due to MDS and beta-thalassemia, marking a significant step toward improving access to advanced anemia therapies across Canada. The approval enables hematologists in the region to offer a targeted alternative to traditional transfusion-heavy approaches, supporting better quality of life for patients
- In August 2023, Bristol Myers Squibb published new real-world evidence in The Lancet Haematology, showcasing sustained hemoglobin improvement and transfusion reduction in MDS patients treated with Reblozyl over a 12-month period. This study supports the clinical utility of erythroid maturation agents and strengthens the evidence base for broader guideline inclusion and payer coverage globally
