The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for roxadustat (FibroGen) for the treatment of anemia of chronic kidney disease (CKD) in both nondialysis-dependent and dialysis-dependent patients.

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, promotes erythropoiesis by increasing endogenous erythropoietin production. In addition, roxadustat improves iron regulation and eases the negative impact of inflammation on hemoglobin (Hb) synthesis and red blood cell production by downregulating hepcidin.

The NDA submission is supported by data from a global phase 3 program that included over 8000 patients. In the OLYMPUS trial (N=2781), roxadustat was associated with a statistically significant and clinically meaningful improvement in mean change from baseline in Hb levels, with a mean increase of 1.75g/dL averaged over weeks 28 to 52, compared with 0.40g/dL with placebo over weeks 28 to 52, in patients with anemia in CKD stages 3, 4, and 5 who are non-dialysis-dependent.

The open-label, active-controlled ROCKIES trial (N=2133) compared the safety and efficacy of roxadustat vs epoetin alfa in the treatment of patients with anemia in CKD who are dialysis-dependent. Results showed roxadustat demonstrated a statistically significant improvement in Hb levels from baseline with a mean increase of 0.77g/dL averaged over weeks 28 to 52, compared with 0.68g/dL with epoetin alfa.

In the phase 3 HIMALAYAS trial (N=1043), roxadustat was found to be superior to epoetin alfa in raising Hb levels in incident dialysis patients (those receiving hemodialysis or peritoneal dialysis for end-stage renal disease for a minimum of 2 weeks and a maximum of 4 months) with anemia. Over weeks 28 to 52, mean Hb increased significantly more with roxadustat: 2.57 vs 2.36g/dL.

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“There is significant unmet medical need for patients with anemia of CKD, who have seen only limited advances in the last 3 decades,” said Peony Yu, MD, Chief Medical Officer, FibroGen. “We intend to work closely with the FDA, in collaboration with our partner, AstraZeneca, to make this novel oral therapy available as soon as possible.”

The FDA has set a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020 for the application.

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