CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy
CSL Vifor and Travere Therapeutics have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA Nephropathy (IgAN).
FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN treatment, is currently available in Germany, Austria, and Switzerland. The approval covers all EU member states, Iceland, Liechtenstein, and Norway.
The decision follows positive phase-III PROTECT study results, which showed FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. The drug is approved for adults with primary IgA nephropathy with specific urine protein excretion levels.
This standard approval, granted without changes to the indication, validates the clinical data and marks an important advancement for IgAN patients across Europe.
CSL Vifor e Travere Therapeutics hanno raggiunto un traguardo importante con la conversione da parte della Commissione Europea dell'approvazione condizionata di FILSPARI in un'autorizzazione standard per la commercializzazione nel trattamento della nefropatia da IgA (IgAN).
FILSPARI, l'unico Antagonista Doppio dei Recettori Endotelina e Angiotensina (DEARA) approvato in Europa per la terapia della IgAN, è attualmente disponibile in Germania, Austria e Svizzera. L'approvazione si estende a tutti gli stati membri dell'UE, Islanda, Liechtenstein e Norvegia.
La decisione segue i risultati positivi dello studio di fase III PROTECT, che hanno dimostrato come FILSPARI rallenti significativamente il declino della funzione renale in due anni rispetto all'irbesartan. Il farmaco è approvato per adulti con nefropatia primaria da IgA e livelli specifici di escrezione proteica nelle urine.
Questa approvazione standard, concessa senza modifiche all'indicazione, conferma la validità dei dati clinici e rappresenta un importante progresso per i pazienti con IgAN in tutta Europa.
CSL Vifor y Travere Therapeutics han alcanzado un hito significativo con la conversión por parte de la Comisión Europea de la aprobación condicional de FILSPARI a una autorización estándar para su comercialización en el tratamiento de la nefropatía por IgA (IgAN).
FILSPARI, el único Antagonista Dual de Receptores de Endotelina y Angiotensina (DEARA) aprobado en Europa para el tratamiento de IgAN, está disponible actualmente en Alemania, Austria y Suiza. La autorización cubre todos los estados miembros de la UE, Islandia, Liechtenstein y Noruega.
La decisión sigue a los resultados positivos del estudio PROTECT de fase III, que demostraron que FILSPARI ralentiza significativamente el deterioro de la función renal durante dos años en comparación con irbesartán. El medicamento está aprobado para adultos con nefropatía primaria por IgA con niveles específicos de excreción de proteínas en orina.
Esta aprobación estándar, otorgada sin cambios en la indicación, valida los datos clínicos y representa un avance importante para los pacientes con IgAN en toda Europa.
CSL Vifor와 Travere Therapeutics가 유럽연합 집행위원회로부터 FILSPARI의 조건부 승인을 일반 허가로 전환받으며 중요한 이정표를 달성했습니다. 이는 IgA 신병증 (IgAN) 치료를 위한 것입니다.
FILSPARI는 유럽에서 IgAN 치료를 위해 승인된 유일한 이중 엔도텔린 안지오텐신 수용체 길항제 (DEARA)로, 현재 독일, 오스트리아, 스위스에서 이용 가능합니다. 이번 승인은 EU 회원국 전역과 아이슬란드, 리히텐슈타인, 노르웨이까지 적용됩니다.
이번 결정은 3상 PROTECT 연구의 긍정적 결과에 따른 것으로, FILSPARI가 이르베사르탄 대비 2년간 신장 기능 저하를 유의미하게 늦췄음을 보여줍니다. 이 약물은 특정 요단백 배설 수준을 가진 성인의 원발성 IgA 신병증 치료에 승인되었습니다.
표준 허가로의 전환은 적응증 변경 없이 임상 데이터를 입증하며, 유럽 전역 IgAN 환자들에게 중요한 진전을 의미합니다.
CSL Vifor et Travere Therapeutics ont franchi une étape importante avec la conversion par la Commission européenne de l'approbation conditionnelle de FILSPARI en une autorisation de mise sur le marché standard pour le traitement de la néphropathie à IgA (IgAN).
FILSPARI, le seul Antagoniste double des récepteurs de l'endothéline et de l'angiotensine (DEARA) approuvé en Europe pour le traitement de l'IgAN, est actuellement disponible en Allemagne, en Autriche et en Suisse. L'autorisation couvre tous les États membres de l'UE, l'Islande, le Liechtenstein et la Norvège.
Cette décision fait suite aux résultats positifs de l'étude de phase III PROTECT, qui ont montré que FILSPARI ralentit significativement le déclin de la fonction rénale sur deux ans par rapport à l'irbésartan. Le médicament est approuvé pour les adultes atteints de néphropathie primaire à IgA avec des niveaux spécifiques d'excrétion protéique urinaire.
Cette autorisation standard, accordée sans modification de l'indication, valide les données cliniques et constitue une avancée importante pour les patients atteints d'IgAN à travers l'Europe.
CSL Vifor und Travere Therapeutics haben einen bedeutenden Meilenstein erreicht, da die Europäische Kommission die bedingte Zulassung von FILSPARI in eine reguläre Marktzulassung für die Behandlung der IgA-Nephropathie (IgAN) umgewandelt hat.
FILSPARI, der einzige in Europa für die IgAN-Behandlung zugelassene Duale Endothelin-Angiotensin-Rezeptor-Antagonist (DEARA), ist derzeit in Deutschland, Österreich und der Schweiz erhältlich. Die Zulassung gilt für alle EU-Mitgliedstaaten sowie Island, Liechtenstein und Norwegen.
Die Entscheidung basiert auf den positiven Ergebnissen der Phase-III-Studie PROTECT, die zeigte, dass FILSPARI den Rückgang der Nierenfunktion über zwei Jahre im Vergleich zu Irbesartan signifikant verlangsamte. Das Medikament ist für Erwachsene mit primärer IgA-Nephropathie und bestimmten Proteinurie-Werten zugelassen.
Diese reguläre Zulassung, die ohne Änderungen der Indikation erteilt wurde, bestätigt die klinischen Daten und stellt einen wichtigen Fortschritt für IgAN-Patienten in ganz Europa dar.
- European Commission granted standard marketing authorization for FILSPARI, upgrading from conditional approval
- Approval covers all EU member states plus Iceland, Liechtenstein and Norway, significantly expanding market reach
- FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for IgAN treatment in Europe
- Phase-III PROTECT study showed significant improvement in slowing kidney function decline over two years
- Product already commercially available in key markets: Germany, Austria and Switzerland
- None.
Insights
EU's conversion to standard approval for FILSPARI reduces regulatory risk and strengthens market position for CSL Vifor/Travere's IgAN treatment.
The European Commission's decision to convert FILSPARI from conditional to standard marketing authorization represents a significant regulatory milestone for CSL Vifor and Travere Therapeutics. This conversion substantially reduces regulatory uncertainty for the companies, as standard approvals typically require less frequent renewal compared to the annual reviews needed for conditional approvals.
The approval maintains the original indication without modifications, covering adults with primary IgA nephropathy with urine protein excretion ≥1.0 g/day. This unchanged indication scope is noteworthy as it validates the strength of the phase-III PROTECT trial data. The regulatory pathway progression follows the expected sequence: conditional approval in April 2024, positive CHMP recommendation in February 2025, and now standard approval.
FILSPARI's position as the only Dual Endothelin Angiotensin Receptor Antagonist approved for IgAN treatment in Europe provides a unique competitive advantage in the non-immunosuppressive therapy space. The current limited availability in just three European markets (Germany, Austria, Switzerland) suggests we're still in early commercialization stages, with this standard approval likely accelerating broader European market access.
FILSPARI's standard EU approval validates its efficacy in slowing IgAN progression, offering patients a needed non-immunosuppressive treatment option.
The conversion to standard marketing authorization for FILSPARI is clinically significant for IgA nephropathy patients across Europe. This rare kidney disease leads to progressive kidney function deterioration that can ultimately require dialysis or transplantation. The phase-III PROTECT study data clearly demonstrated FILSPARI's ability to significantly slow kidney function decline over a two-year period compared to irbesartan, an established treatment option.
What's particularly valuable about FILSPARI is its mechanism as a Dual Endothelin Angiotensin Receptor Antagonist (DEARA). This approach targets multiple pathways involved in IgAN progression without immunosuppression, which represents an important advancement for patients who need alternatives to standard care.
For patients with proteinuria ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g), this approval confirms they now have access to a therapy that addresses a fundamental aspect of disease progression. The indication parameters align with clinical practice thresholds where intervention is typically warranted to prevent further kidney function deterioration.
This full approval should facilitate broader access for patients beyond the current availability in Germany, Austria and Switzerland, addressing an unmet need in IgA nephropathy management across Europe.
European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)
Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025
EU approval is based on the complete data set from the phase-III PROTECT study
ST. GALLEN,
"The decision by the European Commission is an important advancement for people living with IgAN in the EU", said Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor. "The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across
The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across
The European Commission's decision follows CHMP's recommendation to convert the CMA to standard MA from February 2025. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal phase-III PROTECT study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.
FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in
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, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne,
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 (IgAN)
IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein 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 IgAN may include swelling (edema) and high blood pressure.
While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (
About the PROTECT study
The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head vs. comparator 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 sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least
The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. eGFR is a blood test that measure how well kidneys filter waste products from blood. Treatment emergent adverse events were well-balanced between sparsentan and irbesartan, except for dizziness and hypotension.
About FILSPARI (sparsentan)
FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist 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
For more information, please refer to the Summary of Product Characteristics (SmPC).
CSL Vifor Media Contact
Thomas Hutter
+41 79 957 96 73
media@viforpharma.com
Travere Therapeutics:
Investors
888-969-7879
ir@travere.com
Media
888-969-7879
mediarelations@travere.com
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SOURCE Vifor International AG (CSL Vifor)
FAQ
What is FILSPARI's new EU approval status for IgA Nephropathy treatment (CSLLY)?
Where is FILSPARI currently available in Europe for IgA Nephropathy patients?
What makes FILSPARI unique in treating IgA Nephropathy in Europe?
What clinical evidence supported FILSPARI's standard EU approval?
Who can receive FILSPARI treatment under the new EU approval?
