Bristol Myers Squibb gets EMA Committee positive opinion for Reblozyl for adults with Transfusion-Dependent Anemia due to Low-to Intermediate-Risk Myelodysplastic Syndromes
Princeton: Bristol Myers Squibb has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU.
The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial. Results from the primary analysis showed 60.4% (n=110) of patients treated with Reblozyl vs. 34.8% (n=63) of patients treated with epoetin alfa achieved the primary endpoint of red blood cell (RBC) transfusion independence of at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001). Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.
“The positive recommendation by CHMP for Reblozyl can provide an important first-line treatment option for patients with lower-risk MDS in Europe,” said Anne Kerber, M.D., senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “Current treatments, including erythropoiesis stimulating agents, provide limited benefit against anemia. Results from the head-to-head COMMANDS study show that Reblozyl delivered transfusion independence in nearly twice the number of patients compared with epoetin alfa, and with a longer duration of response.”
