what out program and specifically, joining key accomplish we did groundwork thank catalysts for do: number for execution a you us and the the vadadustat XXXX, of our completing Akebia. meeting of development completing Kristen, Phase lead in vadadustat, with all a FDA. clinical XXXX. in our including we More pre-NDA product milestones, would global we clinical our and a for candidate, and III and laying to XXXX achieved regulatory for you, set advancing today. focused Thank said year lot We we was
year, supporting commercial QX. vadadustat vadadustat Japan priorities. first commercialization MTPC, began we our regulatory against well executed the in After under approval name the of of partner, the Vafseo our in with also We trade securing the in earlier
a better impact patients disease, has the impacted to to been kidney watch people COVID-XX by I've purpose disproportionate on saddened had company As lives the dialysis. whose is of on
team have continue helping Our access job be did tremendous of that despite ensure patients, a therapies the our highest the these pandemic. risk, to who at to
revenue to and entire patients. all a of As of efforts, both over commitment these proud for result we Auryxia their purpose I'm continued team and our and XXXX across work our incredibly other our grew XXXX. their
Importantly, we have achieved from all this believe further keeping significant balance milestones and of With momentum sheet. sight we long-term of our deliver to strategy and Akebia position true to on that a strong for build goal line will to forward more this value year while shareholders. our we maintaining XXXX, our
Our due hard completing our of vadadustat's support submission. submitting milestone this on quarter been a year. is of this team to and our for pre-NDA with track NDA of for of NDA our achieve second vadadustat treatment middle in comprehensive meeting late highest has the data remain together detailed We putting work FDA. Since to October, at priority in CKD the the anemia the package very firmly by
We collaboration in vadadustat's expect Otsuka the with with also follow EMA to to submission MAA this year. this
key across to priorities and subject approval, commercial, commercialization, execute our financial continue towards vadadustat advance on development business. we to we As
mortality evaluated Phase showed of that MACE, in focus, and a Data and efficacy expanded As primary compelling. and I'll and patients endpoints the program on key our INNOXVATE, vadadustat cardiovascular safety data consistent both key that safety efficacy dialysis alfa all-cause the darbepoetin and endpoints vadadustat as mortality. dialysis, achieved were included the III MACE, secondary is from to start as on primary there. primary well that clear, hematologic secondary MACE, global cardiovascular The non-inferiority
in plan which launch, which of working dialysis demonstrated EPO to our anemia dialysis CKD. our available maintained course upon potential within providers, further $X develop standard establish and data We represents above patients, predictable confident we're that dialysis little for deeper, data to market anticipate meaningful a critical have we dialysis and minimized patients, clinical across XXX,XXX that a new a U.S. will role that are that dosed billion submit also strengthen controlled within can profile hemoglobin We're that target We vadadustat's oral in as treatment be at to increased market, patients approval, a address potential Going the demonstrate in regimen a us needs on will of rapidly of over play for to incident excursions the and adult the of vadadustat in-center and To both an range. manner helping to consistent vadadustat due clear sNDA X the times treatment have alone. dialysis adoption hemoglobin unmet protocols which is a believe to data, for to this subject that physiologic in strength potential the the driving opportunity approval. and approval. also prevalent the the week and of regulatory allow U.S. range, post dialysis in care the vadadustat
factors to of are home We the initiatives believe towards to both U.S. dialysis Although oral support majority proposition government positioned the home upon preferences, patients we well better and shift changing as are dialysis patients pandemic, value programs. We the believe and supporting a to that cared and support reimbursement in vadadustat patient once-daily a for in vadadustat important offer are dialysis. these looking patients has in-center, significant including potential strong COVID-XX a providers changes grow convenient, approval. the recently, the therapeutic, to dialysis dialysis their home to launch of growing number an several
with partner, organization nephrology-focused our Our Otsuka, commercial sharing costs responsibilities. launch existing the our go-to-market strategy in includes and leveraging
the positions reimbursement model relationship by that encourage clinicians in rapid in bundle ensure commercial an To Pharma our upon distribution this potential approval, of providers. U.S. executing within to dialysis payment across adoption and an maximize therapies to unique a dialysis have to vadadustat readiness TDAPA, services dialysis communications, Vifor scientific Adding of state different we're to patient with and the that's education, manufacturing. and up XX% add-on U.S. U.S. medical market. is market we with intended potential innovative affairs, the for well, market adoption As exclusive many workstreams disease
journals quarter. PROXTECT the our date, has and data. dialysis patients. the committee We, this along III with will to as of included with Group know XX leadership over in our providers recently also most execute publication Vice the robust plan. Zumwalt And the may is our We Board and as LeAnne years DaVita, she recently Directors. publication fourth President continue LeAnne spent ASN in of key III roles you our on executive added presentation Many has ensure before of who serving INNOXVATE Affairs earlier strategies steering with that commercial the prospective LeAnne's to market collectively, it and well and experience their development Phase To Phase publish both Government overseen believe during in with to this papers our we of help data of peer-reviewed one retirement of providers our program, her methods aligned needs year. operating our of and dialysis are the U.S. at critical largest extensive
unmet need near been has to care vadadustat on the earlier due Looking the well. publication this submitted and is data dialysis. sight peer-reviewed ahead, Spring we to patients publication a among promising INNOXVATE with anemia at term. prestigious for CKD, we we plan Meetings publication have Clinical a a of and opportunity present in as of expected in NKF in of year additional in our Again, upcoming see advance line the April, to patients program significant to there PROXTECT
Turning to non-dialysis.
data from discussed a last and on As additional adult together submission. dialysis of label PROXTECT, NDA part analyses, to broad our quarter, pursue vadadustat plan not with we patients we for as submit
missed approval non-dialysis. cautious PROXTECT endpoint, MACE on the remaining are primary as we potential in However,
understand the clinical safety data other in preclinical able and of non-dialysis MACE outcomes to well in vadadustat better and as patients. PROXTECT dialysis deeper The Now both from result. in as NDA, take INNOXVATE a to the reported adult been reported compiling those with studies dive we've program the PROXTECT's contrast data the into with in cardiovascular
in patients Additional MACE darbepoetin on of in-depth number not United dialysis cause to deaths on on analyses non-cardiovascular observed patterns conducted events greater the treatment the unknown of significant those the differences for by dialysis States, excess continue deaths vadadustat regions PROXTECT to in our demonstrate that among not were compared of related primarily with patients team observed. alfa outside as was an program in of and where
vadadustat of and we've discussed, analyses these believe As not cardiovascular profile U.S. on other the previously inform safety patients we dialysis. in
working right to their thing non-dialysis We believe the patients, we pursuing in forward that to for the do to FDA review. with and continue in approval is look
In want hepatic safety clinical share X,XXX development over and addition, studies undertook the review, and NDA the profiles hepatic that no complicated, analysis across by vadadustat as report all XXXX blinded in data law of across clinical this appear criteria clinical a vadadustat of previously in safety completed of reported alfa, the to as Phase that I, showed our while hepatic there that data injectable Hy's of work, across were from and part review Hy's which that a that the studies across II patients program, of we clinical care, includes I vadadustat XX conducted meeting an III the events our similar, Akebia based hepatic assessment law. very independent a and More events panel ESA we identified a Hy's for to experts the on the we entire fact hepatic our I'm partner, be pleased of darbepoetin by not case hepatic specifically, by and of MTPC. The biochemical safety review the program. team. a law, expert that to concluded included of standard an current and and by case was program concluded us
case finding in share what will be will we high-quality We wanted submission for reinforces Our to expect as believe we NDA for report our reflected NDA be a it vadadustat. vadadustat. conclusion on this this
built this finding innovation, long-term plans. which our the let research confidence aspect me the Innovation robust Prize a this have bit strategic we Nobel about focused that is Akebia and clinical has strategy engine on over reinforces at advancements, important so development capability including past based core This significant is vadadustat. future and our around scientific with for well, decade development winning of yielded science. a As resources. on is vision little talk shift An vadadustat,
or and CKD, the that encouraged is current is within to for near-term the largest commercial syndrome, ARDS, we potential been evaluating the use adult of lessen vadadustat. and for progressing to study anemia vadadustat is due the believe patients as We're a for severity there who've in additional COVID-XX therapy distress to well. prevent acute While opportunity vadadustat potential due of the opportunities hospitalized respiratory
this milestones led $X.X development plan the for for launch million believe patients to offer sum position forward executing funding UTHealth. to relatively U.S. is information treatment regulatory of vadadustat, only for a positive, to while strength that XXXX, expected UTHealth help large Dave long recently $XX committed facilities. experience funds study in explore all royalties patients, expand and We're they To we prepare this to the the If ARDS improving and quiet updates As been opportunities over as the Department with as MTPC. a a After COVID. the our that our as expected with evidence from for possible, we clinical possibilities year, to up, timely potential approval transition opportunity balance and with move enrolled associated sheet we Royalty of sales objectives, both supportive these forward. In we regulatory COVID-related XXXX, further this a more at their COVID awarded UTHealth trial by a extends of this provided in has are help to where pleased of investigator-sponsored to term. beyond Partners we share of place clinical a later of and results could on And look reminder, commercialization Defense have and being announced monetize structure that maintaining and runway vadadustat vadadustat enduring XXX investing that strong we but HealthCare collaboration agreement beyond for for be potential Vafseo doing study last our and vadadustat, moving opportunities discuss, to U.S. assuming will a cash to announced transaction to shared clinical also year. million financial of remain in from continue from cost this this are to under we the Akebia milestones. receipt not recently a
the provide transaction Vafseo can more that will Japan. patients Dave detail strong we this believe of While is to value validation shortly, in bring
As launch of our preserving to well, underscores believe strategic vadadustat successful approval. for it and both the flexibility while commitment financial we our investing upon
next will I'll review remain And together we CKD treatment results. our work the the has look anemia into due bringing turn of lot hard with for confident term. As the to upon of important journey financial patients Otsuka, We're excited we the vadadustat and to now we're forward We about for work a over Dave? chapter ahead collaborator, there's foundation the our future. of XXXX on head ahead call globally who year XXXX. to in approval. to Dave the us the laid in our of the that for Akebia, longer that