Letter to the FDA Opposing Approval of Daprodustat and Other Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors

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In a letter to the Food and Drug Administration (FDA), Public Citizen urged FDA not to approve daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHD) inhibitor, or any other HIF-PHD inhibitors for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis, because drugs of this class do not offer patients any additional benefits but have significant additional risks.

January 20, 2023, FDA response letter.