FibroGen Announces Positive Topline Results from Three Global Phase 3 Trials of Roxadustat
FibroGen (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI), met all primary efficacy endpoints in the three global pivotal Phase 3 trials conducted by FibroGen: ANDES in non-dialysis-dependent (NDD) chronic kidney disease (CKD) patients, HIMALAYAS in incident … Continued
FibroGen (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI), met all primary efficacy endpoints in the three global pivotal Phase 3 trials conducted by FibroGen: ANDES in non-dialysis-dependent (NDD) chronic kidney disease (CKD) patients, HIMALAYAS in incident (newly initiated) dialysis patients, and SIERRAS in dialysis-dependent (DD) CKD patients.
As quoted in the press release:
“Anemia in CKD is a serious condition for which a significant number of patients are left without treatment options in many markets,” said Thomas B. Neff, Chief Executive Officer, FibroGen. “These Phase 3 results demonstrate the potential for roxadustat to be a first-in-class oral anemia therapeutic for CKD patients. This is the first well-controlled CKD anemia program that has shown improved efficacy in incident and stable dialysis patients relative to ESA standard of care therapy.”
Each of the three studies had a pre-specified primary efficacy endpoint for meeting U.S. regulatory requirements and another pre-specified primary efficacy endpoint for meeting EU regulatory requirements, which also served as a secondary efficacy endpoint for the U.S. Both the U.S. and EU primary efficacy endpoints were met in all three studies.
