OROXAT patients reached and maintained target Hb
Patients treated with OROXAT reached target Hb levels and remained within the target range
DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent; FAS, full analysis set; Hb, haemoglobin; IDD, incident dialysis-dependent; NDD, non-dialysis-dependent; SE, standard error.
OROXAT patients maintained target Hb on a stable dose
Patients maintained target Hb levels on a stable dose of OROXAT
- The dose of OROXAT remained stable up to Week 104
DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent; FAS, full analysis set; Hb, haemoglobin; IDD, incident dialysis-dependent; NDD, non-dialysis-dependent; SE, standard error.
OROXAT Hb levels comparable with ESA
Patients treated with OROXAT achieved and maintained Hb levels comparable with ESA
The Phase Ill DOLOMITES study evaluated the efficacy and safety of OROXAT compared to darbepoetin-alfa for the treatment of anaemia in NDD patients with stage 3-5 CKD. In the primary endpoint analysis, the study demonstrated non-inferiority of OROXAT to darbepoetin-alfa in the proportion of patients achieving correction of Hb levels during the first 24 weeks of treatment (89.5% vs. 78%, respectively)
CKD, chronic kidney disease; CI, confidence interval; DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent; EOT, end of treatment; Hb, haemoglobin; IDD, incident dialysis-dependent; NDD, non-dialysis-dependent; PPS, per protocol set.
OROXAT reduced use of IV iron compared with ESA
Fewer patients treated with OROXAT received IV iron than those treated with ESA
- EVRENZO was effective without routine use of IV iron in most patients with non-dialysis dependent CKD
CKD, chronic kidney disease; CI, confidence interval; DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent. IV, intravenous; NDD, non-dialysis-dependent.
OROXAT summary of efficacy in NDD
In non-dialysis-dependent CKD, EVRENZO can help your patients achieve and maintain target Hb levels
- EVRENZO demonstrated statistical superiority in Hb correction and maintenance when compared to placebo and was non-inferior to ESAs in the DOLOMITES trial
- Treatment with EVRENZO resulted in a reduced use of IV iron compared with treatment with ESAs
CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, haemoglobin; IV, intravenous.
Reporting Adverse Events
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to SKF Pharma Ltd. on 0800 783 5018