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.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT