FibroGen Hit with Late Panel Meeting Requirement

FibroGen and partner AstraZeneca say FDA is requiring its Cardiovascular and Renal Drugs Advisory Committee to review their NDA for roxadustat for treating anemia caused by chronic kidney disease (CKD). FDA accepted the NDA 2/2020 and gave it a review action target date of 12/2020, which was extended late last year to 3/20. The advisory panel meeting date has not yet been determined, according to the company.

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.