Comments Submitted to the FDA Regarding the NDA for Roxadustat for Treating Anemia Due to Chronic Kidney Disease

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Public Citizen urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for roxadustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis because the drug offers no unique benefits compared to earlier FDA-approved erythropoiesis-stimulating agents but does have greater risks of serious adverse events, including thromboembolic events.