FibroGen's Roxadustat Meets Primary Goals In Two Phase 3 Anemia Studies In China

(RTTNews) - FibroGen, Inc. (FGEN), a science-based biopharmaceutical company, along with its unit FibroGen China reported positive topline results from the two Phase 3 clinical studies of roxadustat (FG-4592) designed to support new drug application submission in China.

Roxadustat is a first-in-class, orally administered small molecule for treatment of anemia in dialysis-dependent CKD (DD-CKD) and non-dialysis-dependent CKD (NDD-CKD) patients. The company noted that both of the Phase 3 studies met their primary efficacy endpoints, which were evaluated in the comparator-controlled portions of the studies.

In the double-blind, placebo-controlled eight-week portion of the 26-week NDD-CKD trial, 151 anemia patients were randomized 2:1 to receive roxadustat or placebo. Roxadustat met its primary efficacy endpoint of correcting anemia, by achieving a statistically significant increase in hemoglobin levels compared to placebo over eight weeks.

Furthermore, the secondary endpoint of Hb response was met as Hb response was achieved by a higher proportion of patients in the roxadustat arm than in the placebo arm.

FibroGen and AstraZeneca (AZN) are collaborating for the development and commercialization of roxadustat in China, the U.S., and other markets.

In China, FibroGen is conducting all clinical trials and will hold all roxadustat regulatory licenses and permits to be issued by China regulatory authorities. After market approval, FibroGen China will manage manufacturing and medical affairs and AstraZeneca will manage launch and commercialization activities in China.