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Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations

Published on 01/05/20 at 12:32pm

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.

The first is in transfusion-dependent anaemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts in adults who have not responded to or are ineligible for erythropoietin-based therapy, and the second is adults with transfusion-dependent anemia associated with beta thalassemia.

"Patients with myelodysplastic syndromes who experience anemia have limited treatment options, and some have been shown to not respond to available erythropoietin-based therapies," remarked Dr Uwe Platzbecker, lead investigator of the MEDALIST study and Head of Clinic and Policlinic for Hematology and Cell Therapy at Leipzig University Hospital. “If approved, the introduction of a new class of therapy in Reblozyl could provide a promising option to help relieve patients from the burden of regular transfusions to manage their disease.”

The European Commission is not bound by the decision, but traditionally tends to follow the advice of its CHMP. If it is successful, Reblozyl would become the first erythroid maturation agent approved in the EU.

The decision was based on Phase 3 data from the MEDALIST and BELIEVE trials which demonstrated the drug’s efficaxcy and safety in these patient populations.

Matt Fellows

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