Following China approval, FibroGen's anemia drug meets in five additional Phase III trials

FibroGen Inc. (NASDAQ:FGEN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) reiterated plans to submit an NDA to FDA this half for roxadustat to treat anemia in patients with chronic kidney disease (CKD) after the compound met the primary endpoints in five Phase III trials. Roxadustat, a small molecule inhibitor of HIF-PH, is approved in China to treat anemia caused by CKD in patients who are dialysis-dependent (see "China Gives FibroGen its First Approval for Roxadustat").

The five trials were ANDES in non-dialysis-dependent patients; HIMALAYAS in patients who have newly initiated dialysis treatment for end-stage renal disease and have had minimal or no exposure to a erythropoiesis-stimulating agent (ESA); SIERRAS in dialysis-dependent patients receiving stable doses of an ESA; OLYMPUS in non-dialysis-dependent patients; and ROCKIES in dialysis-dependent patients...