FDA Approves First Oral Therapy for Anemia in Dialysis

The Food and Drug Administration recently approved daprodustat (Jesduvroq, GSK) for the treatment of anemia in adults with chronic kidney disease (CKD) who have been on dialysis for at least four months. Daprodustat is the only oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the United States. Other FDA-approved treatments for CKD are injected into the blood or under the skin.

FDA based the approval on results from the ASCEND-D trial, in which adult patients with CKD received either oral daprodustat or injected recombinant human erythropoietin. Results indicated that daprodustat raised and maintained the hemoglobin within the target range of 10-11 grams/deciliter, similar to that of the recombinant human erythropoietin. The most common side effects were high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions.

The approval includes a boxed warning for an increased risk of thrombotic vascular events including death, heart attack, stroke and blood clots in the lungs, legs or dialysis access site. Daprodustat is not approved for patients who are not on dialysis.