presented Last Jim. included III of at American over Nephrology Meeting, you, kidney and roxadustat results Annual Society our the Thank week, XX,XXX professionals. Phase FibroGen partners which
scientific anemia the share on potential As review foundation. game based in to changer like of Today, the excitement would highlights. a nephrologists therapy I strong our
pooled The encompass exposure trials, from Phase III XX,XXX patients patient years. over data over included including and analyses X,XXX X
infarction of participation. Our on months the We a of and recently populations; plus due is MACE or endpoints; simply consists hospitalization dialysis-dependent due consists all nonfatal mortality of all-cause myocardial safety or any death of started due reported stroke; angina, events endpoints nonfatal death patient failure which unstable dialysis to X events MACE+ results MACE incident nondialysis-dependent, and heart adverse cause. studies is dialysis, to X cardiovascular X study's the of major evaluated within causes, subgroup all following to patients
of the an time primary by with is MACE important community. consistency, analyses the which supported the are FDA to in in MACE+, and the assignment. independent on in objectivity pooling based maintain agreed analytical adjudicated strategy conducted To approaches adjudicators time-to-event safety U.S., were endpoint the and cardiovascular to nephrology results endpoints recognized blinded as is by and The endpoint events the treatment these
assessment, placebo, in In In commonly a safety a reduced had nondialysis, compared applied of margin risk noninferiority standard to was roxadustat commonly dialysis alfa of X.X. XX% using is using increased by patients, and margin MACE placebo risk NI comparable was the gold roxadustat where which of and X.X. to applied EPO no roxadustat to compared epoetin MACE+ compared of MACE+ MACE to the risk in
risk risk In a and XX% of than XX% EPO. a MACE roxadustat of incident had lower lower dialysis, MACE+
Similarly, In and and more of advanced Of on Phase stage Let's into X study with patients large thus, these studies range to current ineligible more be CKD of replete XX% whom comparing ESAs. at CKD were were rest and they baseline, III CKD results, with X have non-iron from X they X, anemia efficacy patients. we label. included anemia ESA discuss stores we safety with X. kidney nondialysis based ESA of X,XXX-plus excluded stage starting tends generally placebo. treatment, the for severe to disease, enrolled were included patients XX% the studies their of prior Their and the a the nondialysis. studies, with CKD patients iron chronic been roxadusat
in weeks Roxadustat's mean which baseline primary superior baseline than. X.XXX, to in of -- and of efficacy in risk and at hemoglobin sorry, of each XX iron, which roxadustat iron Phase of repletion III XX, was the use and which in status. anemia IV severity, the blood of includes regardless to ESA an met to the individual Roxadustat less in with reduction average XX% the of pooled is I'm endpoint CKD studies transfusion p-value efficacy accompanied analyses over change X transfusion, a of rescue of red regardless reduction XX% risk in cell and of severity placebo by p-value regardless treatment, from
patients decline of Importantly, measure the baseline in show year patients first in also or in Patients function. placebo, roxadustat is a base -- slower eGFR during with eGFR, treatment. higher which with to kidney a XX comparison of of
been in patients treatment X in the decline with than eGFR less is in decline placebo difference patients year has one a and roxa of in X.X significantly X.X X.X, which that. The p-value was of
reduction This XX% represents placebo. a decline in to relative eGFR
the analysis, Turning on nondialysis cardiovascular comparable based safety. to CKD to In pool placebo. ITT roxadustat was
interval X.XX interval are of reference, hazard X.XX, hazard of of confidence X.XX, ratio confidence a ratios. X.XX, For has a here and with of of and ratio of MACE+ has and with X.XX X.XX confidence the X.XX. X.XX mortality MACE X.XX ratio all-cause interval XX%
overall the we believe nondialysis. We want of that the the the also TREAT true have way, cardiovascular endpoint pool. roxadustat to analyses. nondialysis program consistent with We Well, components comparable of MACE dialysis use dialysis is components the clear and individual in restriction in the interest in the from in most in nondialysis the most results stroke. from patients. composite study of and on in placebo results outset. I Stated in individual are on the another received in to resulted questions because the the this MACE+ the darbepoetin is ESA believe individual be label This its with likely are components the in for data
individual Before into and the for remind I endpoint you program details, to was we the assessing the want components. roxadustat nondialysis MACE that composite power dive not
placebo is is give of a interval only roxadustat to the confidence rate years pool in X.XX which program, of XXX Hazard and magnitude, of arm. in in stroke MACE the XX% in per X.X roxadustat with X.XX. XX% placebo, in sense comparable the X.X X.XX, ratio represents roxadustat nondialysis the versus patient events of of and To incidence
earlier. X.XX stated a and hazard MACE+ of mortality ratio in interval is rate of in incident of TREAT of with requiring ratio As in reminder, of a X.XX. X.XX, MI we X.X and XX% of the interval darbepoetin pool of interval X.XX confidence confidence confidence interval as and and with The stroke and X.XX. X.XX has X.XX of which stable X.XX of a has X.XX angina was confidence the and and twice of of placebo, our component All-cause the ratio hazard X.XX, X.XX, rest nondialysis ratio follows. study that hospitalization
is which hazard requiring congestive failure X.XX, heart Finally, interval confidence ratio important X.XX of patients and of CKD has X.XX. in hospitalization,
patients. receiving requirements of to was than iron week cardiovascular inflammation efficacy Based on IV or as and was individual III active the This CRP dose who primary XX The analyses. hemoglobin to of were baseline regardless endpoints measured comparable alfa. in mean result MACE, composite patients safety dialysis-dependent dialysis inflammation one-to-one patients achieved less in components, The higher endpoint with hemoglobin from mortality placebo. EPO to or epoetin seen to change randomized in XX roxadustat roxadustat by consists roxadustat with patients the pool status of the MACE+, patient than individual study in all-cause of studies. in time met with alfa is of each without X pooled comparator epoetin treated roxadustat level the overall Phase and to receive of similar XXX Roxadustat
of saturation transferrin comparable the body a TSAT, X arms. store or between were While the measure in treatment iron
ratio can compared X.XX, addition, lower EPO, the above In combination with p-value potentially cell benefits utilization, The when of coordinated and roxadustat-treated patients. than ESA treatment as of Hazard lower hyporesponsiveness. efficient of requirement overcome in erythropoiesis reflects red of had resulted transfusion findings more blood roxadustat transfusion a patients risk iron EPO-treated X.XXX. with
EPO. of had and Turning risk in would pool. to risk the had MACE+ roxadustat dialysis In MACE+, in each in cardiovascular roxadustat of of to all-cause point a individual rate analysis components the to compared XX% like increased the to incidence dialysis I mortality, EPO. numerically In endpoint reduction out MACE roxadustat relative are EPO. than no in lower
about which patient dialysis, the talk pre-specified exciting incident of a let's pool. is population, the subgroup Finally, dialysis-dependent
an new participation resulted to months treatment in studied X.X who XX% duration would MACE+ in in anemia in before roxadustat dialysis reduction three average death. we results comparison of a up treatment epoetin study risk trend to dialysis patients pool, initiating with commenced lower suggest year. in In treatment for were within Here, safety dialysis treated X,XXX and long-term incident the of reduction selecting therapy alfa, X years patients. potential XX% benefits risk roxadustat a MACE when of of in the risk These and the
the put improve CKD this if into is efficacy an evaluate the To patients. merits to and potential taking of and to overall anemia in together it safety roxadustat, important account ask picture, treatment drug has
scale answer is, transfusion iron In while in III equal function greater XX, patients the all-cause placebo, Phase in down comparable nondialysis, roxadustat with corrected Our decline reduced gold kidney risk were yes. our slowing program of while and standard. mortality to repletion show treatment of blood to of than large anemia EGFR and or also effectively risk MACE,MACE+ use the regardless
that requirement the currently USRDS patients ESA, reported administration coupled inconvenience unlike of with treatment. of office. as ESA approved, treatment XX% benefits the iron and in the ESA the requires convenience requirements, at nondialysis Because ESA, safety-related little of dialysis parenteral entering restriction of there repletion injections only use of frequent with is If a deliver patients, could the doctor's roxadusat prior pill, therapeutic of had which the received
In safety believe improve the unprecedented the removal oral from we compliance. whose characteristics, access dosing millions therapy opportunity treatment go to convenient Therefore, favorable addition stock to potential roxadustat the patients the anemia we we and to of unaddressed. the and need to have medication believe nondialysis an has inject and efficacy expand medicine, anemia time patient to and patients financial and the burden of of
compared at in generally risk With MACE of we a alfa in from safer believe chronic compared use epoetin the choice reduction for with without In dialysis, benefiting in inflammation rate XX% roxadustat in with option and dialysis anemia initiating risk IV or a dialysis periods in could MACE+ to patients. early reduction patients be the of currently, efficacy agent robust XX% transfusion the patients, a patients made incident treatment. lower decision viewed is EPO while on iron dialysis less with as and the the dialysis,
patients both before new and in the year-end. anemia in Working privileged dialysis We and have safety approval results the Europe these serve both with winning NDA strong as patients CKD for U.S., demonstration results for in potentially we a dialysis. indications for to roxadustat, efficacy not for agent in by marketing submit NDA substantial the Nobel on an countries the CKD are based believe therapy science. other a for with AstraZeneca, to world. in first-in-class our a introduce of benefits above anemia clinical on standard opportunity We basis partner, We on plan to accompanied patients could have with compelling made progress preparing
are MAA XXXX. first with to our Astellas, working for quarter the and both closely expect We the file European in of indications partner
nontransfusion-dependent Phase global in we safety Orlando study II/III have Hematology results lead-in MDS, other U.S. in clinical results will and treatment be MDS the of the open-label patients study study a portion, Society in presented to month. of patients efficacy of by MDS session upcoming we the patients American in roxadustat Encouraged next of in MDS III and demonstrating expand China. continue III From in an efficacy CKD, Meeting in studies; X transfusion-dependent anemia of oral Phase global Phase a etiologies. ongoing In
of have of much need the population. have also started roxadustat anemia opportunity which for believe We a treating large unmet address study II to Phase a U.S. we to chemotherapy-induced patient
HIF-PHI therapy. for pioneering anemia led CEO founding Our
to Neff's are on legacy improve We to medicines carry Tom innovative develop committed care. to patient
to call Chung. Chris to like now over the I turn
