England's NICE recommends FILSPARI® as a treatment option for IgA nephropathy

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About IgA nephropathy

Primary immunoglobulin A nephropathy (IgA nephropathy) is a rare, progressive type of chronic kidney disease (CKD) that is often diagnosed in adults before the age of 40 years.6 CKD is characterised by abnormalities of kidney function or structure that have been present for more than three months and can be categorised into five stages dependent on functionality of the kidney.13 Dialysis (a medical treatment used to artificially filter waste products and excess fluids from the blood when the kidneys are unable to perform this function adequately)14 or kidney transplantation is recommended for patients whose kidneys have reached an advanced stage (typically, stage 5).15  More than 60 per cent of adult patients diagnosed with IgA nephropathy are in CKD stage 3 or higher.6 Patients with this condition may experience blood in the urine (red or dark brown urine), foamy urine from protein leaking into the urine, flank pain, swelling (oedema), high blood pressure, and fatigue.16

About FILSPARI® (sparsentan)

Sparsentan was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. Sparsentan is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialisation rights for sparsentan in Europe, Australia and New Zealand. Sparsentan is anticipated to be available to patients in the UK in the second half of 2025.

Sparsentan is the first and only non-immunosuppressive treatment for IgA nephropathy that has two modes of action.1 This single molecule functions as a high affinity, dual-acting antagonist of both the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R).4 Sparsentan inhibits activation of both ETAR and AT1R, both of which play a role in regulating processes in the kidney, such as inflammation, that lead to progression of kidney damage.4

About PROTECT  

NICE's recommendation is based on data from the pivotal Phase 3 PROTECT study4 of sparsentan in IgA nephropathy, one of the largest interventional studies to date in IgA nephropathy and the only head-to-head trial in this rare kidney disease. It is a global, randomised, multicentre, 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 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy.4,17

The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance.4 After 36 weeks of treatment, patients receiving sparsentan (n=202) 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 (n=202).4,17 Treatment emergent adverse events and serious adverse events were well-balanced between sparsentan and irbesartan, except for dizziness (30 [15%] vs 13 [6%] patients) and hypotension (26 (13%] vs eight (4%] patients).4 For more information, please refer to the Summary of Product Characteristics (SmPC).18,19

References:

Trachtman H, et al. Sparsentan: the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy. Expert Rev Clin Immunol. 2024 Jun;20(6):571-576. doi: 10.1080/1744666X.2024.2319132.Komers R, et al. Dual inhibition of renin-angiotensin-aldosterone system and endothelin-1 in treatment of chronic kidney disease. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R877-84. doi: 10.1152/ajpregu.00425.2015.NICE Draft Final Guidance on sparsentan (May 2025).Rovin BH, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4.Travere Therapeutics and CSL Vifor Announce Standard EU Approval of FILSPARI® (sparsentan) for IgA Nephropathy; press release (April 2025).Pitcher D, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727–38.av.Reich HN, et al. Remission of proteinuria improves prognosis in IgA nephropathy. J Am Soc Nephrol. 2007;18:3177–83.Sharma S, et al. From Proteinuria to Fibrosis: An Update on Pathophysiology and Treatment Options. Kidney Blood Press Res. 2021;46:411?20.Bagchi S, et al. Supportive Management of IgA Nephropathy With Renin-Angiotensin Blockade, the AIIMS Primary IgA Nephropathy Cohort (APPROACH) Study. Kidney Int Rep. 2021 Feb 26;6(6):1661-1668. doi: 10.1016/j.ekir.2021.02.018. PMID: 34169207; PMCID: PMC8207308.European Medicines Agency (EMA). (2020) Orphan designation for the treatment of primary IgA nephropathy https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2345 (accessed May 2025).Barratt J, et al. Therapy of IgA nephropathy: time for a paradigm change. Front Med (Lausanne). 2024 Aug 15;11:1461879. doi: 10.3389/fmed.2024.1461879. PMID: 39211339; PMCID: PMC11358106.KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Disease, Kidney International (2021) 100, S1-S276 https://kdigo.org/wp-content/uploads/2017/02/KDIGO-Glomerular-Diseases-Guideline-2021-English.pdf (accessed May 2025).NKF Kidney Disease Stages https://kidneycareuk.org/kidney-disease-information/stages-of-kidney-disease/stages-of-chronic-kidney-disease-ckd/ (accessed May 2025).NKF Haemodialysis https://kidneycareuk.org/kidney-disease-information/treatments/patient-info-haemodialysis-hd/ (accessed May 2025).NKF Transplants for All https://www.kidney.org/transplantationNKUK Transplantation https://www.kidneyresearchuk.org/transplantation/ (accessed May 2025).Mayo Clinic What is IgA Nephropathy? https://www.mayoclinic.org/diseases-conditions/iga-nephropathy/symptoms-causes/syc-20352268 (accessed May 2025).Heerspink HJL, et al. PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1. PMID: 37015244.Filspari EU131-SmPC_SPT_UK_200mg UK SmPC (May 2025).Filspari EU131-SmPC_SPT_UK_400mg UK SmPC (May 2025).

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Job no: UK-SPT-25000110  Date: 23 May 2025

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