GSK plc (NYSE:GSK)
An impartial panel of FDA specialists will convene in October to review the company’s marketing application for daprodustat, an oral treatment for people with anemia caused by chronic kidney disease (CKD), according to a Tuesday statement from GSK plc (NYSE:GSK).
Daprodustat, which is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) with a PDUFA action date of February 1, 2023, is now being reviewed by the FDA for chronic kidney disease.
On October 26, 2022, the FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet to discuss GSK’s (GSK) daprodustat NDA.
According to Chris Corsico, senior vice president of development at GSK, “we believe daprodustat and the outcomes exhibited in the ASCEND clinical trial program have tremendous potential for individuals living with CKD anemia who presently do not have an oral therapy choice.” Data from the ASCEND phase III program support the company’s marketing application for daprodustat.
Phase III clinical research program for ASCEND
The ASCEND program involves five phases III investigations in order to evaluate daprodustat’s effectiveness and safety profile for the management of CKD-related anemia across the illness spectrum. Over 8,000 patients were enrolled in the program, and they received to care for a maximum of 4.26 years. At Kidney Week 2021, sponsored by the American Society of Nephrology, findings from all five trials were presented.
ASCEND-ND and ASCEND-D, two crucial cardiovascular outcomes studies that looked at patients who were not on dialysis and who were on dialysis, respectively, also published their findings in the New England Journal of Medicine.
Relating to chronic kidney disease and anemia
The impact on global public health of CKD, which is characterized by a progressive decrease in renal function, is rising. Hypertension, diabetes, obesity, and primary renal diseases are all risk factors for CKD.
GSK is a multinational biopharmaceutical business with the mission of bringing talent, technology, and science together to fight disease.
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