FDA panel votes against use of Roxadustat for anaemia in CKD patients
FibroGen, Inc., a leading biopharmaceutical company headquartered in San Francisco recently announced that the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) under the Food and Drug Administration (FDA) in the United States have unanimously voted to disprove the use of Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients.
The Committee backed its recommendation on a pool of information from a global Phase 3 program including more than 8,000 patients.
Chronic kidney disease (CKD) is usually a progressive disorder characterized by complete loss of kidney function that may ultimately cause kidney failure or end-stage renal disease, requiring dialysis or kidney transplant. While, anemia, which is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is often an early complication of CKD, affecting at least 20 percent of CKD patients.
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