New Oral Option for patient with Anemia due to CKD on Dialysis
On February 1, 2023, the FDA approved GlaxoSmithKline’s oral therapy, Jesduvroq (daprodustat), for the treatment of anemia due to chronic kidney disease (CKD) on dialysis.1 Notably, sources estimate that over 500,000 patients of the 700,000+ with end-stage CKD meet the classification of being on dialysis.2
Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Jesduvroq works by inhibiting enzymes that stabilize factors which cause hypoxia and lead to transcription of erythropoietin and other genes involved in the correction of anemia.3 After more than 30 years, Jesduvroq is the first oral treatment option in a category that has been largely limited to products that require administration by injection (e.g., erythropoietin stimulating factors (ESAs), such as epoetin alfa, darbepoietin)3-6.
Approval of Jesduvroq is based on data from the ASCEND-D trial of more than 2,900 patients who received treatment for up to 4.26 years. Findings demonstrated that Jesduvroq improved or maintained the patients’ hemoglobin at target levels (10g/dL-11.5g/dL). It also achieved “non-inferiority” of MACE (Major Adverse Cardiac Events) compared to controls receiving darbepoetin or epoetin alfa after a median follow-up period of 2.5 years.3
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 (e.g., gemfibrozil). Similar to erythropoietin stimulating factor products, the prescribing information for Jesduroq 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.3
Jesduvroq is supplied as 1mg, 2mg, 4mg, 6mg, and 8mg tablets and 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.2 Although daprodustat is NOT approved for non-dialysis CKD patients (a much larger patient group), GlaxoSmithKline is seeking an approval in this broader CKD population. More than 1 in 7 (i.e. 15% of the US adult population or approximately 37 million people) are estimated to have CKD.7
Jesduvroq offers added convenience with oral administration, but it will take time for providers to gain confidence with the product due to the long-standing track record and experience with injectable options. Annual cost for these products varies with dose.
- Jesduvroq is estimated to cost ~ $11,000 - $25,000.
- Injectable options (Epoetin, Procrit, Retacrit, and Aranesp) run ~ $17,000 - $41,000.
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- 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. Found at: https://www.prnewswire.com/news-releases/fda-approves-first-oral-treatment-for-anemia-caused-by- chronic-kidney-disease-for-adults-on-dialysis-301736770.html. Accessed 02/4/2023.
- NIH” Kidney Disease Statistics for the United States. Found at: https://www.niddk.nih.gov/health- information/health-statistics/kidney-disease Accessed 2/6/2023.
- Jesduvroq. Package insert. GlaxoSmithKline. February 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216951s000lbl.pdf. Accessed 2/4/2023.
- Procrit (epoetin alfa). Janssen Pharmaceuticals. July 2018. Found at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/PROCRIT- pi.pdf. Accessed 2/4/2023.
- Epogen (epoetin alfa). Amgen, Inc. July 2017. Found at https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Epogen/epogen_pi_hcp_english.pdf. Accessed 2/4/2023.
- Aranesp (darbepoetin alfa). Amgen, Inc. January 2019. Found at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Aranesp/ckd/aranesp_pi_hcp_english.pdf. Accessed 2/4/2023.
- CDC. Found at https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html. Accessed 02/6/2023.