EU body endorses wider label for BMS anaemia drug

23 Feb 2024
firstwordpharma.com
Clinical ResultCell Therapy
Bristol Myers Squibb has convinced advisors to the European Medicines Agency that the label for its anaemia therapy Reblozyl (luspatercept) should be expanded to include first-line patients with low- to intermediate-risk myelodysplastic syndromes (MDS). The agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for this lower risk population on Friday.
Existing treatments such as drugs that boost red blood cell production have so far demonstrated limited benefit against anaemia, says Anne Kerber, head of late clinical development at Bristol Myers Squibb for haematology, oncology and cell therapy.
"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," she said.
Data from the trial showed that 60.4% of patients in the Reblozyl arm and 34.8% of those receiving epoetin alfa did not need blood transfusions for at least 12 weeks, the study's primary endpoint. Reblozyl als increased patient haemoglobin levels by ≥1.5 g/dL in the first 24 weeks of treatment.
If approved, it would represent the latest authorised indication for Reblozyl in the EU following earlier nods in beta-thalassaemia and in transfusion-dependent anaemia among patients with very low, low and intermediate-risk MDS who haven't responded adequately to erythropoietin-based therapy, or are considered unsuitable candidates for such therapy.
US regulators cleared the erythroid maturation agent in the first-line setting for lower-risk MDS patients last August. Reblozyl brought in sales of just over $1 billion last year, up 41% compared with 2022.
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