FibroGen NDA for Chronic Kidney Disease Anemia

FDA has accepted for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients. The agency has set a user fee review action target date of 12/20. The NDA filing triggers a $50 million milestone payment from AstraZeneca, the company says.
 

Roxadustat is described by FibroGen as a small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor. It is designed to promote erythropoiesis through increasing endogenous production of erythropoietin, as well as improving iron regulation, the company says.
 

The submission is supported by data from a global Phase 3 program involving more than 8,000 patients. Roxadustat is currently approved in China for treating anemia in patients with CKD, regardless of whether they require dialysis, and in Japan for treating CKD patients with anemia on dialysis,