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Daniel W. Coyne

In 2018, expert opinion that our present strategies for the use of intravenous (IV) iron were harming chronic kidney disease (CKD) patients took a severe thrashing. Despite clear evidence that iron is essential for treating the anemia of CKD, generous IV iron use has been discouraged by guidelines and by many experts. Despite this advice, physicians in the United States have given more IV iron to dialysis patients than those in other regions of the world. The results from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial, paired with the results from IV iron trials that include nondialysis

Daniel W. Coyne

For more than 30 years, erythropoiesis-stimulating agents (ESAs) have reigned supreme as the treatment for chronic kidney disease (CKD)–related anemia. Can hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs) topple ESAs? HIF-PHIs are oral medications taken three times a week or daily and have been shown in trials to achieve and maintain goal hemoglobin to the same degree as ESAs. HIF-PHIs are small molecules that inhibit the prolyl hydroxylase enzyme that continually marks the HIF for degradation. Each dose transiently increases intracellular HIF2a, a transcription factor, leading to activation of a series of genes, including erythropoietin (EPO) and several iron transport genes. Consequently,

Daniel W. Coyne

FibroGen's roxadustat was dreaming of being the first-in-class hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) for treatment of chronic kidney disease (CKD)-related anemia. FibroGen submitted its new drug application to the US Food and Drug Administration (FDA) in December 2019 and suggested roxadustat safety was comparable to placebo and comparable or superior to erythropoiesis-stimulating agents (ESAs) in its global trials.

The dream became a nightmare at the July 15, 2021, FDA Advisory Committee meeting, where a panel of 14 experts overwhelmingly advised against approval of roxadustat for use in anemic non-dialysis or dialysis patients. The FDA is not required to follow the