medical our to activities RAS Good we afternoon. where FILSPARI the as enable I'll and full are inhibitors providing of to for IgA focused care. and education on achieve foundational support FILSPARI ensuring XXXX start replace approval with nephropathy
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both development tandem is the critical that at using medicine approved options juncture an in the effective in both IgA will is as we where will or these of approaches seeing exciting progression are or the effects future more and in there nephropathy. no arrest in are improvements We these independently, of include addressing This of ways. single
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in top on elsewhere directly been targeting inhibitors has works but, comparing similar pathway. else what that of is on added disease cascade the not RAS to and/or Everything unfortunately,
targeted nephrologists will add kidney immune-mediated then FILSPARI move use we foundational ahead, we As medications as needed. as a upstream therapy and believe
that experience FILSPARI they increasing recommendations for their choice foundational to are at care risk in who we progression. further is not by remain utilize validated guidelines more replace RAS treatment algorithms therapy with nephrologists, eligible for And patients with the this and surprisingly, IgAN patients. Perhaps are as from continuously making hearing inhibitor in FILSPARI to FILSPARI, they are as gaining
X FILSPARI study, data meaningful clinically presented long-term from benefit subgroup also in we of range a impact of we full PROTECT baseline have We at to believe preservation at levels, approval. At range of generate had the for it a with and analyses kidney data. a a across new continue describing years on positive supportive additional the Congress potentially is Nephrology signifies treatment that subgroups. This function wide that label can supportive broad World proteinuria our broadening meeting, FILSPARI recent proteinuria demonstrating
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data to proteinuria. can is presented inhibitors SGLTX showed we safe that adding Additionally, and FILSPARI further reduce
longer-term and at results upcoming these of Collectively, supportive earlier congresses. to providing are use, look forward we and results broader
treatment treatment towards field their to the will and kidney we recognized earlier from for as have diagnosis This also earlier good anticipated every opportunity full intervening and, day is are hear belief support risk revision. losing disease. patients educate function. They with time is IgAN to the paradigm patients. be following earlier As care foundational for lifetime that evolve, the to hold in don't moving approval, thought on further This in leaders these the continues and upcoming ourselves of the wait guideline KDIGO to us they provide widely a
milestones start key the our regulatory Now to turning to year.
with assigned X to pleased target of date this earlier, were highlighted receive an very our we Review Priority Eric PDUFA for year. action of As sNDA September
Additionally, do that to plan the have they meeting to communicated advisory FDA discuss has application. not committee an the
engaging process, to forward work including on review the FDA We the with to liver monitoring. throughout look REMS for continuing
are conditional authorization than receive preparation We the only per per are to Europe. the day with partnership CSL Commission in patients It presently to FILSPARI note is full marketing next to decision nephropathy FILSPARI X.XX medicine than CMA IgA approval, X to for that step greater in and proteinuria in grant pleased gram a also supporting with recent submission the with is greater to transitioning or process for important The Vifor. European Europe gram. is grams we
their with approval to also other Japan submission our regions. has Japan, study We announced ultimate progress support in that Asia made IND in recently and partner an advancing Renalys, Pacific and
I'll provide FSGS. a update brief on
we in a and identify hopeful for an Our indication additional the efforts FILSPARI. to that able be for FSGS continue forward in background, will path remain we
with they around to approval FSGS the eGFR from late is FDA, would a the which and NephCure, and partnership is outcomes. present data relationship PARASOL, ASN define therapies to patients, goal FSGS to efforts, that their EMA for parallel with plan point help align kidney sets data on public-private together world Their and of October. the our academia, an In is proteinuria, in bringing between end new support at
completion. the the near data will and We PARASOL once work to appropriate time reengage at is to continue our FDA compile with
in program HCU our discuss III me let Now Phase development.
disease-modifying continue living as with therapy patient potential lives to medical potential there adboards to excited recently is be advocates conferences, very pegtibatinase and the and deliver first leaders for for of about change We our HCU. people to with the and engaged pegtibatinase We HCU. at enthusiasm about significant HCU thought positively the
often cause HCU HCU, low events enzyme diets. nor intake of the that life. directly only can aspects treatment the The approved. pegtibatinase, need to address negatively as do believe thrombotic and medical change the help risk address for help of impact the These nutritional key patients social address achieve We adequate require available therapy options or that not protein do underlying they many formula drinking daily the targeting if in can of defect
study. the pleased the dosed in first HARMONY have are We pivotal to patients achieved
adherence supply As of for as enrollment stages and we commercial discussed, have use. high-quality program scale protocol our the we've to earlier the metering continue we and in duration our we the are ensure to
and anticipate feedback we're far, in from positive to getting sites, top continue line data we our XXXX. So
patients allow protein from to or start open-label and for also diet This enter end exploratory ENSEMBLE into generating data eligible Phase important will tolerance begin study. this our for COMPOSE our we to quarter, to This sub-study will modification I/II point. on transition COMPOSE trial our patients
pleased team diseases. with are programs, with rare summary, is working each which at talented in the deliver are therapies people to passionate the about testament we who for In Travere of a life-changing to progress our living
Let to commercial a it over me update. for Peter? Peter now turn
