Research & Development
US FDA approves Celgene and Acceleron Pharma's Reblozyl
12 November 2019 -

The US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) intended for the treatment of anaemia in beta thalassemia in adults requiring regular red blood cell (RBC) transfusions, it was reported yesterday.

The product is an erythroid maturation agent that was co-developed by Celgene and Acceleron Pharma.

According to Celgene, the US FDA -approved drug is a new class of therapy that is intended to regulate late-stage maturation of red blood cells for decreasing the RBC transfusion burden for patients. According to the FDA, supportive treatment for people having beta thalassemia usually includes lifelong regimens of chronic blood transfusions for survival and treatment for iron overload caused by the RBC transfusions. Patients with beta thalassemia also have an increased risk of developing abnormal blood clots, according to the regulator. The FDA approval for the product was based on the data from the phase three BELIEVE trial. The late-stage study assessed the safety and efficacy of the drug for the treatment of anaemia in beta thalassemia in 336 adults, who require regular RBC transfusions.

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