The FDA has set a PDUFA date for daprodustat for February 1 for adult patients with chronic kidney disease.
Quality of life enhancements should be of consideration when developing new drugs for patients with chronic kidney disease (CKD).
The good news is 1 such drug might soon be on the way in daprodustat.
During the American Society of Nephrology’s Kidney Week, investigators presented new data showing daprodustat resulted in improvements in hemoglobin, as well as increases in vitality scores for fatigue in adult patients with anemia of CKD.
The data came from the phase 3 ASCEND trial of 614 non-dialysis dependent patients with CKD. The results show a greater proportion of patients treated with daprodustat had at least a 1 g/dl increase in hemoglobin from baseline (77% vs 18%; P <0.001), while the adjusted mean SF-36 Vitality score increased by 7.3 points in the daprodustat group compared to 1.9 points in the placebo group.
The rates of adverse events were also similar between the 2 groups.
In an interview with HCPLive®, Kirsten L. Johansen, MD, Hennepin Healthcare, University of Minnesota, explained why it is so challenging to treat diseases, while simultaneously addressing fatigue issues for the patients.
She also spoke on the prospect of daprodustat, which has a Prescription Drug User Fee Act (PDUFA) date set by the US Food and Drug Administration (FDA) for February 1.