February 01, 2023 -- Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at least four months.
“With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia,” said Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases.”
Daprodustat, a HIF-PHI, belongs to a novel class of oral medicines indicated for the potential treatment of anaemia of CKD in adult patients not on dialysis and on dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia. Daprodustat has been developed to provide a convenient oral treatment option for patients with anaemia of CKD.
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