Posted by Michael Wonder on 01 May 2020
Reblozyl (luspatercept) receives positive CHMP opinion for the treatment of adults with anaemia in beta thalassemia and myelodysplastic syndromes
1 May 2020 - Recommendation for approval based on results from pivotal Phase 3 MEDALIST and BELIEVE studies.
Bristol Myers Squibb and Acceleron Pharma today announced that the CHMP of the EMA has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of:
- Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.
- Adult patients with transfusion-dependent anemia associated with beta thalassemia.
