The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the approval of Bristol Myers Squibb’s (BMS) Reblozyl (luspatercept) as a first-line treatment for anaemia in adults with myelodysplastic syndromes (MDS). 

The CHMP granted a positive opinion based on the Phase III COMMANDS trial (NCT03682536). The primary endpoint – red blood cell (RBC) transfusion independence for at least 12 weeks with a mean haemoglobin increase of at least 1.5g/dL within the first 24 weeks – was achieved by 60.4% of patients treated with Reblozyl compared to 34.8% of patients treated with epoetin alfa, a drug used to treat anaemia. Safety findings were consistent with previous MDS studies and expected symptoms in this patient population. 

MDS are a group of blood disorders characterised by abnormal bone marrow function, resulting in low blood cell counts and an increased risk of leukaemia. Symptoms include fatigue, weakness, and increased susceptibility to infections and bleeding. Treatment options range from supportive care to stem cell transplantation, depending on the subtype and severity of the condition.  

Reblozyl has been developed and marketed through a worldwide partnership with Merck (MSD), following the latter’s $11.5bn acquisition of Acceleron Pharma in November 2021.  

The drug is approved in the EU for adult patients with transfusion-dependent anaemia due to certain types of MDS, as well as for anaemia associated with beta-thalassemia. In the US, it’s approved for anaemia in adult beta-thalassemia patients requiring regular blood transfusions, anaemia in adult MDS patients who may need regular transfusions, and anaemia in adult MDS patients who have failed previous treatments. 

Reblozyl generated $1bn in 2023, as per BMS’s annual report. According to GlobalData’s Pharma Intelligence Center, Reblozyl is forecast to generate $3.17bn in 2029, with the anticipated expanded label contributing to a growth in sales. 

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In BMS’ announcement, Anne Kerber, BMS’ senior vice president for haematology, oncology, and cell therapy, said: “The positive recommendation by CHMP for Reblozyl can provide an important first-line treatment option for patients with lower-risk MDS in Europe. Current treatments, including erythropoiesis-stimulating agents, provide limited benefit against anaemia.”