The U.S. Food and Drug Administration (FDA) approved Jesduvroq (daprodustat – GSK) tablets on Feb. 1, 2023. The first drug in a new class, hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI), is an oral therapy indicated for treating adults who have anemia resulting from chronic kidney disease (CKD) and who have needed dialysis for four months or longer. To treat anemia of CKD, Jesduvroq is taken once daily. Initial doses range from 1mg to 12mg, with increases to an upper limit of 24mg/day depending on the patient’s hemoglobin levels, liver function, and other drug treatments. Doses can be modified at four-week intervals, but Jesduvroq should be discontinued if hemoglobin levels do not improve adequately after 24 weeks. It is not intended for patients who do not need dialysis. Plans for pricing, launching, and distributing Jesduvroq have not been announced. Look here for its complete prescribing information.

At a Glance

• Brand (Generic) Name: Jesduvroq (daprodustat)
• Manufacturer: GSK
• Date Approved: Feb. 1, 2023
• Indication: treat anemia due to chronic kidney disease for adults who have been receiving dialysis for at least four months.
• Dosage Forms Available: 1mg, 2mg, 4mg, 6mg, and 8mg tablets
• Launch Date: Not yet known
• Estimated Annual Cost: Not yet known
• The National Kidney Foundation (NKF) estimates that about 37 million American adults have some degree of CKD, which advances through five stages.
• Anemia affects roughly 15% of all patients who have CKD, with percentages increasing for older patients, those in later stages of CKD, and those who have co-existing conditions.
• In 2018, approximately 500,000 patients needed regular sessions of dialysis to replace kidney function, according to the NKF.
• Current treatment for anemia associated with CKD includes injected erythropoiesis (EPO) stimulating agents (ESA), such as epoetin alfa and darbepoetin alfa, iron replacement, and red blood cell (RBC) transfusions.
• Jesduvroq is the first FDA-approved HIF-PHI, a class of drugs that treats anemia by stabilizing hypoxia-inducible factors, thereby enhancing transcription of genes, such as erythropoietin, that stimulate RBC production and alleviate anemia.
• In the ASCEND clinical studies, Jesduvroq, the first FDA-approved drug for oral use in CKD- induced anemia, was comparable in effectiveness to an ESA for achieving and maintaining goals for hemoglobin blood levels.
• Before treatment with Jesduvroq starts, patients should be tested for liver enzymes and blood levels of iron. Continuing iron replacement is likely during therapy with it.
• A boxed warning cautions that taking Jesduvroq may raise the risks of blood clots, heart attacks, strokes, and death; so the lowest effective dose should be used.