Renal anemia is a common complication of chronic kidney disease (CKD). Although treatments—such as iron therapies, erythropoiesis-stimulating agents (ESAs), and HIF-PH inhibitors—are available, physicians, patients, and healthcare systems are concerned about their limitations. Agents of the novel HIF-PH inhibitor class, roxadustat and vadadustat, received a complete response letter (CRL) from the FDA (in August 2021 and March 2022, respectively) over safety concerns, despite being approved in Japan and Europe. In the United States, daprodustat has become the first HIF-PH inhibitor to launch for renal anemia patients who have been on dialysis. The U.S. launch of the second HIF-PH inhibitor, vadadustat, for the treatment of anemia due to CKD in adult patients on dialysis is expected during the study period. Although these new therapies offer advantages over current therapies, they will face major challenges, including reimbursement hurdles and an increasingly stringent regulatory environment.
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