BMS anaemia therapy Reblozyl wins expanded EU approval

2024-04-03

上市批准临床结果

Bristol Myers Squibb’s Reblozyl (luspatercept) gained approval in Europe to include the first-line treatment of adults with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). US regulators cleared the erythroid maturation agent in this indication last August.

Monica Shaw, head of European markets at Bristol Myers Squibb, said the approval means “more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available.”

The decision by the European Commission, which comes after a European Medicines Agency panel recommended approval in February, was supported by findings from the head-to-head COMMANDS study. Results 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, meeting the trial’s the primary endpoint. Bristol Myers Squibb’s drug also increased patient haemoglobin levels by ≥1.5 g/dL in the first 24 weeks of treatment.

Reblozyl, which is part of a collaboration with Merck & Co., is also approved in Europe for 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.

Reblozyl brought in sales of just over $1 billion last year, up 41% compared with 2022.

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