Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), successfully treats anemia in patients with chronic kidney disease (CKD), including those initiating or continuing dialysis therapy, according to updated findings presented during the virtual National Kidney Foundation 2021 Spring Clinical Meetings.
Robert Provenzano, MD, of Wayne State University in Detroit, Michigan, and colleagues reviewed pooled data from the 6 phase 3 roxadustat trials involving more than 8000 patients for key efficacy endpoints: rise in hemoglobin (Hb), red blood cell (RBC) transfusion, and monthly intravenous (IV) iron infusion. All results were statistically significant.
In the nondialysis-dependent CKD trials, roxadustat was associated with a greater mean increase in Hb level (1.85 vs 0.13 g/dL) and a lower risk of RBC transfusion (5.2% vs 15.4%) compared with placebo.
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In the incident dialysis trials, roxadustat was associated with a greater mean increase in Hb level (2.12 vs 1.91 g/dL) compared with epoetin alfa. RBC transfusion rates were similar, but roxadustat-treated patients had lower mean IV iron requirements (53.6 vs 70.2 mg per patient exposure month).
In the prevalent dialysis trials, roxadustat was associated with a greater mean increase in Hb level compared with epoetin alfa (1.21 vs 0.99 g/dL). A smaller proportion of the roxadustat group compared with epoetin alfa recipients required RBC transfusion (9.5% vs 12.8%). Roxadustat recipients also had lower mean IV iron requirements (52.2 vs 66.8 mg per patient exposure month).
Roxadustat both promotes erythropoiesis and improves iron availability, according to Dr Provenzano and colleagues. The HIF-PHI is currently under review by the FDA. In December 2020, the FDA requested further clarifying analyses of the clinical data. In March 2021, AstraZeneca and FibroGen announced that the FDA’s Cardiovascular and Renal Drugs Advisory Committee will convene to review the new drug application.
Roxadustat is already approved in China, Japan, and Chile and is undergoing review in the European Union.
Disclosure: The roxadustat clinical trials were supported by AstraZeneca, FibroGen, and Astellas. Please see the original references for a full list of authors’ disclosures.
References
Provenzano R, Fishbane S, Szczech L, et al. Efficacy of roxadustat across stages of chronic kidney disease. Presented at the virtual National Kidney Foundation 2021 Spring Clinical Meetings, April 6-10, 2021. Poster 173.
Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease [press release]. AstraZeneca; March 1, 2021.
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease [press release]. AstraZeneca; December 18, 2021.
