Akebia's vadadustat shows efficacy in late-stage study in kidney disease-related anemia

• Akebia Therapeutics (NASDAQ:AKBA) has reported additional data from the INNO₂VATE Phase 3 trial comparing its vadadustat to darbepoetin alfa (similar to erythropoietin) in adult patients on dialysis with chronic kidney disease-related anemia. Data were presented at the American Society of Nephrology Kidney Week.
• Data presented builds on the positive top line efficacy and safety results from the study previously reported in May. More specifically, new data showed vadadustat achieved non-inferiority to darbepoetin alfa on major adverse cardiovascular event (MACE), as well as in analyses of expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality.
• Most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa-treated patients - hypertension (16.2%/ 12.9%); diarrhea (10.1% / 9.7%). Serious treatment-emergent adverse events were 49.7% vs. 56.5%.
• During prevalent dialysis patient study, incidence of adverse events in vadadustat vs. darbepoetin alfa-treated patients was 88.3% and 89.3%, respectively. Most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa-treated patients - Diarrhea (13.0% / 10.1%), pneumonia (11.0% / 9.7%), hypertension (10.6% / 13.8%), and hyperkalemia (9.0% / 10.8%). Serious treatment-emergent adverse events were 55% vs. 58.3%.
• https://seekingalpha.com/news/3625250-akebias-vadadustat-shows-efficacy-in-late-stage-study-in-kidney-disease-related-anemia