FDA approval for BMS and Acceleron’s Reblozyl to reduce red blood cell transfusion dependence

pharmafile | April 6, 2020 | News story | Manufacturing and Production, Sales and Marketing BMS, FDA, Reblozyl, pharma 

The FDA has given the regulatory thumbs-up in the US of Reblozyl (luspatercept-aamt), the “first and only erythroid maturation agent” according to developers Bristol-Myers Squibb and Acceleron Pharma, in the treatment of patients who rely on red blood cell transfusions.

The drug is approved specifically for the treatment of anaemia which has not responded to an erythropoiesis stimulating agent and which requires  at least two  red blood cell (RBC) units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.

However, the manufacturer added that the drug is not indicated to substitute RBC transfusion in patients in need of immediate anaemia correction.

According to BMS, a “significantly greater proportion” of Rebloyzl patients did not require RBC transfusions for at least eight weeks in the first 24 weeks of the Phase 3 trial compared to those receiving placebo, meeting the study’s main goal.

Furthermore, the data showed that a similarly significant proportion of Reblozyl patients became RBC transfusion-independent for at least 12 weeks within the first 24 and 48 weeks.

“In clinical trials, Reblozyl has shown to have significant benefit for the treatment of anaemia in patients with myelodysplastic syndromes who have ring sideroblasts,” said Dr Guillermo Garcia-Manero, Professor and Chief of Section of Myelodysplastic Syndromes, Department of Leukemia at the University of Texas MD Anderson Cancer Center. “Anaemia is a serious consequence of MDS, requiring the majority of these patients to receive regular red blood cell transfusions, which can lead to additional complications, such as iron overload, transfusion site reactions and infections. In our current environment, we are reminded of the significant burden frequent blood transfusions can have on individuals and the healthcare system.”

This is the second approved indication for Reblozyl – it’s first came last year in November in anaemia in adults with beta thalassemia who require regular RBC transfusions.

Matt Fellows

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