CSL Vifor and Travere Therapeutics Recognize Updated KDIGO Clinical Practice Guidelines for IgA Nephropathy
CSL Vifor (OTC:CSLLY) and Travere Therapeutics announced recognition of updated KDIGO clinical practice guidelines for IgA Nephropathy (IgAN) treatment. The 2025 guidelines highlight their drug FILSPARI® (sparsentan) as a potential first-line treatment approach, being the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) with proven efficacy compared to optimized RASi in clinical trials.
The updated guidelines establish key treatment goals including proteinuria remission and slowing eGFR decline. FILSPARI, which is approved in the U.S. and Europe, has been launched in multiple European countries including Germany, Austria, Switzerland, Luxembourg, and the UK. The guidelines were presented at the International Symposium of IgA Nephropathy in September 2025.
CSL Vifor (OTC:CSLLY) e Travere Therapeutics hanno annunciato il riconoscimento delle linee guida cliniche KDIGO aggiornate per il trattamento della Nefropatia da IgA (IgAN). Le linee guida 2025 evidenziano il loro farmaco FILSPARI® (sparsentan) come potenziale trattamento di prima linea, essendo l'unico Dual Endothelin Angiotensin Receptor Antagonist (DEARA) con efficacia dimostrata rispetto all'RASi ottimizzato nei trial clinici. Le linee guida aggiornate stabiliscono obiettivi chiave di trattamento tra cui la remissione della proteinuria e la rallentamento del declino dell'eGFR. FILSPARI, approvato negli Stati Uniti e in Europa, è stato lanciato in diversi paesi europei tra cui Germania, Austria, Svizzera, Lussemburgo e Regno Unito. Le linee guida sono state presentate all'International Symposium of IgA Nephropathy nel settembre 2025.
CSL Vifor (OTC:CSLLY) y Travere Therapeutics anunciaron el reconocimiento de las directrices clínicas KDIGO actualizadas para el tratamiento de la Nefropatía por IgA (IgAN). Las directrices de 2025 destacan su medicamento FILSPARI® (sparsentan) como un posible enfoque de tratamiento de primera línea, siendo el único antagonista dual de receptores de endotelina y de angiotensina (DEARA) con eficacia probada en comparación con RASi optimizados en ensayos clínicos. Las directrices actualizadas establecen objetivos de tratamiento clave, incluida la remisión de la proteinuria y la desaceleración de la caída de la eGFR. FILSPARI, aprobado en Estados Unidos y Europa, se ha lanzado en varios países europeos, incluidos Alemania, Austria, Suiza, Luxemburgo y el Reino Unido. Las directrices fueron presentadas en el International Symposium of IgA Nephropathy en septiembre de 2025.
CSL Vifor (OTC:CSLLY)와 Travere Therapeutics는 IgA 신병증(IgAN) 치료를 위한 업데이트된 KDIGO 임상 실무 지침의 인정을 발표했습니다. 2025년 지침은 그들의 약물 FILSPARI®(sparsentan)를 잠재적 1차 치료 접근으로 강조하며, 임상시험에서 최적화된 RASi에 비해 입증된 효능을 가진 유일한 Dual Endothelin Angiotensin Receptor Antagonist (DEARA)입니다. 업데이트된 지침은 단백뇨 관해 및 eGFR 감소의 속도 저하를 포함한 주요 치료 목표를 제시합니다. 미국과 유럽에서 승인된 FILSPARI는 독일, 오스트리아, 스위스, 룩셈부르크, 영국 등 여러 유럽 국가에서 출시되었습니다. 이 지침은 2025년 9월 IgA 신병증 국제 심포지엄에서 발표되었습니다.
CSL Vifor (OTC:CSLLY) et Travere Therapeutics ont annoncé la reconnaissance des directives cliniques KDIGO mises à jour pour le traitement de la Néphropathie IgA (IgAN). Les directives 2025 mettent en évidence leur médicament FILSPARI® (sparsentan) comme une approche potentielle de premier recours, étant le seul DEARA (Dual Endothelin Angiotensin Receptor Antagonist) avec une efficacité démontrée par rapport au RASi optimisé dans les essais Cliniques. Les directives actualisées fixent des objectifs de traitement clés, notamment la rémission de la protéinurie et le ralentissement du déclin de l'eGFR. FILSPARI, approuvé aux États-Unis et en Europe, a été lancé dans plusieurs pays européens dont l'Allemagne, l'Autriche, la Suisse, le Luxembourg et le Royaume-Uni. Les directives ont été présentées lors de l'International Symposium of IgA Nephropathy en septembre 2025.
CSL Vifor (OTC:CSLLY) und Travere Therapeutics gaben die Anerkennung der aktualisierten KDIGO-Klinik-Leitlinien für die Behandlung der IgA-Nephropathie (IgAN) bekannt. Die Leitlinien 2025 heben ihr Medikament FILSPARI® (sparsentan) als potenzielle Erstbehandlung hervor, da es der einzige Dual Endothelin Angiotensin Receptor Antagonist (DEARA) mit nachweislicher Wirksamkeit im Vergleich zu optimiertem RASi in klinischen Studien ist. Die aktualisierten Leitlinien legen zentrale Behandlungsziele fest, darunter Remission der Proteinurie und Verlangsamung des eGFR-Verlusts. FILSPARI, in den USA und Europa zugelassen, ist in mehreren europäischen Ländern eingeführt worden, darunter Deutschland, Österreich, Schweiz, Luxemburg und das Vereinigte Königreich. Die Leitlinien wurden beim International Symposium of IgA Nephropathy im September 2025 vorgestellt.
CSL Vifor (OTC:CSLLY) و Travere Therapeutics أعلنوا اعترافهم بإرشادات KDIGO السريرية المُحدّثة لعلاج اعتلال الكلية المناعي IgA (IgAN). تبرز إرشادات 2025 دواءهم FILSPARI® (sparsentan) كنهج علاج أوّلي محتمل، فهو الوحيد من فئة DEARA (مضاد مجسات الإندوتيلين والريتينان) ذو فعالية مثبتة مقارنة بـ RASi المحسن في التجارب السريرية. تحدد الإرشادات المحدثة أهداف علاجية رئيسية بما في ذلك الشفاء من البروتينوريا وإبطاء انخفاض معدل الترشيح الكبيبيeGFR. FILSPARI، المعتمد في الولايات المتحدة وأوروبا، قد أُطلق في عدة دول أوروبية منها ألمانيا والنمسا وسويسرا ولوكسمبورغ والمملكة المتحدة. تم تقديم الإرشادات في المؤتمر الدولي لاعتلال IgA الكلوي في سبتمبر 2025.
CSL Vifor (OTC:CSLLY) 与 Travere Therapeutics 宣布更新的 KDIGO 临床实务指南在 IgA 病变肾病（IgAN）治疗方面的认可。2025 年指南将他们的药物 FILSPARI®（sparsentan） 突出为潜在的一线治疗方案，是唯一在临床试验中相对于优化的RASi具有证据支持的 双内皮素-血管紧张素受体拮抗剂（DEARA）。更新的指南确立了包括蛋白尿缓解和减慢 eGFR 下降在内的关键治疗目标。FILSPARI 已在美国和欧洲获批，并已在德国、奥地利、瑞士、卢森堡和英国等多个欧洲国家推出。该指南于 2025 年 9 月在 IgA 肾病国际研讨会上公布。
- FILSPARI recognized as potential first-line treatment in updated KDIGO guidelines
- Only therapy with proven efficacy vs optimized RASi in clinical trials
- Successfully launched in multiple European markets
- Strong clinical evidence supporting role as foundational treatment
- None.
Insights
KDIGO's updated guidelines recognizing FILSPARI for IgA nephropathy treatment strengthens its market position and supports CSL Vifor's revenue outlook.
The inclusion of FILSPARI® (sparsentan) in the updated KDIGO clinical practice guidelines represents a significant clinical validation for CSL Vifor and Travere Therapeutics. These new guidelines position FILSPARI as potentially appropriate for first-line treatment for IgA Nephropathy (IgAN) patients at risk of progressive kidney function loss, departing from the traditional RAS inhibitor-first approach.
What makes this particularly noteworthy is that FILSPARI is explicitly highlighted as the only therapy with proven efficacy compared to optimized RASi in clinical trials. The PROTECT study enrolled more patients than all prior RASi trials combined, giving substantial weight to these recommendations. The guidelines also establish clear treatment goals: remission of proteinuria (
From a commercial perspective, these guidelines will likely influence prescribing patterns significantly. Formal inclusion in treatment guidelines typically accelerates adoption among nephrologists and can help with reimbursement justifications. With FILSPARI already launched in the US, Germany, Austria, Switzerland, Luxembourg, and UK, these guidelines should strengthen its market positioning.
The dual mechanism of FILSPARI as a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) addresses the treatment approach recommended in the guidelines - simultaneously targeting IgAN-induced nephron loss and IgA formation. This mechanistic alignment with guideline recommendations further solidifies its clinical positioning for this rare kidney disease.
FILSPARI® (sparsentan) suggested for IgA Nephropathy patients who are at risk of progressive kidney function loss
ST. GALLEN,
The 2025 update defines remission of proteinuria (<0.5 g/day, or ideally at <0.3 g/day) and slowing eGFR decline as key treatment goals. To achieve these goals, the guidelines recommend a treatment approach with therapies simultaneously targeting IgAN-induced nephron loss and IgA-formation.
Within the guidelines it is mentioned that treatment with FILSPARI® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), may be an appropriate first-line approach to manage the responses of IgAN-induced nephron loss in contrast to the RASi-first approach. The guidelines also highlight FILSPARI as the only therapy with proven efficacy compared to optimized RASi in clinical trials — with more patients enrolled in PROTECT than in all prior RASi trials combined.
"The updated KDIGO guidance represents an important step forward for the IgA Nephropathy community," said Prof. Dr. med. Jürgen Floege, Senior Professor, Div. Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany. "For patients and clinicians, this provides greater clarity and confidence in navigating treatment decisions, with the ultimate goal of improving long-term kidney outcomes."
"The new IgA Nephropathy management recommendations provide important guidance for clinicians treating this rare disease. The inclusion of FILSPARI in the KDIGO guidelines is a reflection of its benefit-risk profile and reinforces its role in helping eligible patients reduce proteinuria and slow kidney function loss, while being generally well-tolerated", said Dr. Achim Obergfell, Global Medical Head Nephrology Portfolio CSL Vifor. "The updated KDIGO guidelines mark an important milestone for the IgA nephropathy community, reflecting advances in disease understanding, more sophisticated risk assessment and therapies," said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. "The placement of FILSPARI underscores the strong clinical evidence supporting its role as a foundational treatment and offers clinicians with clear, evidence-based guidance to improve patient care."
The now published KDIGO clinical practice guidelines represent a focused update of Chapter 2: IgA Nephropathy/IgA Vasculitis from the KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. It sets out to provide a comprehensive and evidence-based framework for healthcare professionals to diagnose, treat, and manage these two types of glomerular diseases. The full guidance was presented at the International Symposium of IgA Nephropathy in September 2025 and will be published as a supplement to the Official Journal of the International Society for Nephrology.
FILSPARI is a non-immunosuppressive therapy for the treatment of IgA Nephropathy approved in
About the PROTECT Study
The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only Phase 3 head-to-head trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of FILSPARI (sparsentan), compared to 300 mg of irbesartan, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving at least
The trial met the pre-specified primary endpoint which showed that after 36 weeks patients receiving FILSPARI (n=202) achieved a mean reduction in proteinuria from baseline of
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen,
For more information about CSL Vifor, visit CSL.com.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.
About IgA Nephropathy
IgA Nephropathy, also called Berger's disease, is a rare progressive kidney disease characterized by the abnormal buildup of immunoglobulin A (IgA), an antibody that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgA Nephropathy may include swelling (edema) and high blood pressure.
While rare, IgA Nephropathy is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgA Nephropathy is estimated to affect more than 250,000 people in the licensed territories.
About FILSPARI (sparsentan)
FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist (DEARA) with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).
FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA Nephropathy in the
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FAQ
What are the key updates in KDIGO 2025 guidelines for IgA Nephropathy treatment?
How does FILSPARI (sparsentan) differ from other IgA Nephropathy treatments?
In which countries is FILSPARI currently available?
What is the significance of FILSPARI's inclusion in the KDIGO guidelines for CSL Vifor (CSLLY)?
When will the full KDIGO 2025 guidelines be published?
