PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has backed the approval of Reblozyl (luspatercept) for adult patients with transfusion-dependent anemia resulting from certain risk levels of myelodysplastic syndromes (MDS). The European Commission (EC) will now review the recommendation, which, if approved, would mark the fourth authorized indication for Reblozyl in the European Union.
The CHMP's positive opinion is grounded in the results from the Phase 3 COMMANDS trial, where 60.4% of patients treated with Reblozyl achieved transfusion independence for at least 12 weeks and a concurrent mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks. This is nearly double the 34.8% of patients treated with the alternative, epoetin alfa, reaching the same primary endpoint. Additionally, the duration of response for patients treated with Reblozyl was notably longer compared to those treated with epoetin alfa.
Safety outcomes from the trial were consistent with previous studies involving MDS, aligning with expected symptoms for this patient group. The data also indicated that progression to acute myeloid leukemia and overall deaths were comparable between the two treatment arms.
Anne Kerber, M.D., senior vice president at Bristol Myers Squibb, highlighted the significance of this recommendation for patients with lower-risk MDS in Europe, noting the limited benefits of current treatments against anemia. Reblozyl, as per the COMMANDS study, not only improved transfusion independence but also showed a longer duration of response in comparison to epoetin alfa.
MDS is characterized by the bone marrow's inability to produce healthy blood cells, leading to anemia and the need for frequent blood transfusions. These transfusions carry risks such as iron overload and infections, potentially affecting overall patient survival.
Reblozyl, which promotes the expansion and maturation of late-stage red blood cells, is developed and commercialized through a collaboration with Merck, following their acquisition of Acceleron Pharma (NASDAQ:XLRN), Inc.
The potential expansion of Reblozyl's indication in the EU stands as a testament to Bristol Myers Squibb's ongoing efforts to provide innovative treatments for serious diseases. The information in this article is based on a press release statement.
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