Investor Presentaiton slide image

Investor Presentaiton

Co-primary Efficacy Endpoint: ASCEND-ND Mean Hb change from baseline to the evaluation period (Weeks 28-52) ā€“ ITT Population Daprodustat was noninferior to darbepoetin alfa for mean change in Hb from baseline to the evaluation period (Weeks 28-52) 12 ASCEND ND āœ° Daprodustat Darbepoetin alfa 12.5 Hb concentration (g/dL) NON-DIALYSIS 11.5 11- 10.5 10 9.5 9 8.5 EP WK 148 WK 136 WK 124 WK 112 WK 100 WK 88 WK 76 WK 64 WK 52 WK 40 WK 28 WK 16 WK 4 DAY 1 SCR WK-8 FU EOS Prespecified NI margin: -0.75 g/dL Adjusted Mean Treatment Difference (95% CI)* 0.08 (0.03, 0.13) Noninferiority was achieved because the lower limit of the 95% CI of the treatment difference was greater than the prespecified noninferiority margin of -0.75 g/dL No. of patients Daprodustat Darbepoetin alfa 1936 1932 1866 1705 1511 1364 1254 1100 961 832 725 587 453 349 243 1935 1933 1867 1697 1506 1398 1243 1100 952 835 727 602 482 378 272 1276 1056 1278 1043 *Based on an ANCOVA model using observed and imputed data with terms for treatment, baseline hemoglobin, current ESA use and region. Error bars indicate 95% CI. Post-randomization values include on- and off- treatment values. Visits on or before Day 1 include only pre-treatment values. Horizontal reference lines represent the Hb analysis range (10-11.5g/dL). The Hb target range for dose changes is 10-11g/dL. Vertical dotted lines represent the EP. Cl, confidence interval; EP, evaluation period; EOS, end of study; ESA, erythropoiesis-stimulating agent; FU, follow up; Hb, hemoglobin; ITT, intent-to-treat; NI noninferiority; SCR screening; Wk, week. 12
View entire presentation