Jesduvroq Approved for Anemia of CKD in Patients on Dialysis

The Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat) for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 4 months.

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. The approval was based on data from the phase 3 ASCEND-D trial (ClinicalTrials.gov Identifier: NCT02879305), which included 2964 patients with anemia of CKD who were on dialysis. Patients were randomly assigned to receive daprodustat or a recombinant human erythropoietin (rhEPO; darbepoetin alfa or epoetin alfa). 

The coprimary endpoints were the mean change in the hemoglobin level from baseline to weeks 28 through 52, and the time to first occurrence of adjudicated major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), using a noninferiority comparison to rhEPO.

Results showed that patients in the daprodustat arm achieved a mean change in hemoglobin level of 0.3±0.02g/dL compared with 0.10±0.02g/dL in the rhEPO arm (difference, 0.2g/dL; 95% CI, 0.1-0.2), which met the prespecified noninferiority margin of -0.75g/dL. After a median follow-up of 2.5 years, MACE occurred in 25.2% (n=374/1487) of patients in the daprodustat arm and 26.7% (n=394/1477) of patients in the rhEPO arm (HR, 0.93; 95% CI, 0.81-1.07), which met the prespecified noninferiority margin.

“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, MD, 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.”

The most common adverse reactions reported with Jesduvroq were hypertension, thrombotic vascular events, and abdominal pain. Jesduvroq is contraindicated in patients with uncontrolled hypertension and with concomitant use of strong CYP2C8 inhibitors (eg, gemfibrozil). The prescribing information also includes a Boxed Warning for an increased risk of thrombotic vascular events including death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.

Jesduvroq is supplied as 1mg, 2mg, 4mg, 6mg, and 8mg tablets. It is administered daily without regard to the timing or type of dialysis. Jesduvroq is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia or for treatment of anemia of CKD in patients who are not on dialysis.

References

1. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. News release. US Food and Drug Administration. February 1, 2023. Accessed February 2, 2023. https://www.prnewswire.com/news-releases/fda-approves-first-oral-treatment-for-anemia-caused-by-chronic-kidney-disease-for-adults-on-dialysis-301736770.html.
2. Jesduvroq (daprodustat) approved by US FDA for anemia of chronic kidney disease in adults on dialysis. News release. GSK plc. February 1, 2023. Accessed February 2, 2023. https://us.gsk.com/en-us/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anemia-of-chronic-kidney-disease-in-adults-on-dialysis/.
3. Jesduvroq. Package insert. GSK plc; 2023. Accessed February 2, 2023. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jesduvroq/pdf/JESDUVROQ-PI-MG.PDF.