Sparsentan

FILSPARI holds strong market potential as the first FDA-approved non-immunosuppressive therapy for IgA nephropathy, a rare kidney disease with significant unmet needs. As more patients and providers seek disease-modifying options, FILSPARI is well-positioned to capture substantial market share, especially with favorable long-term data. LAS VEGAS, May 27, 2025 /PRNewswire/ -- DelveInsight's " FILSPARI Market Size, Forecast, and Market Insight Report" highlights the details around FILSPARI, the first and only oral, once-daily, non-immunosuppressive therapy approved in both the US and Europe for IgAN. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FILSPARI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Travere Therapeutics' FILSPARI (sparsentan) Overview FILSPARI (sparsentan) is a once-daily oral treatment that uniquely targets two key pathways, endothelin-1 and angiotensin II (also known as DEARA), in the progression of IgA nephropathy. It is the first approved non-immunosuppressive therapy for this condition. Endothelin-1 and angiotensin II contribute to kidney function decline by promoting inflammation and fibrosis, altering podocyte structure, causing podocyte loss, and increasing the permeability of the glomerular filtration barrier. Additionally, both are vasoconstrictors that narrow blood vessels and raise pressure in the glomeruli. The drug received accelerated approval based on its ability to reduce proteinuria. Due to potential safety concerns, it is distributed under the FILSPARI Risk Evaluation and Mitigation Strategy (REMS) program. In Europe, it is marketed by CSL Vifor, and in Japan by Renalys Pharma. Results from the registration-enabling study are expected in the second half of 2025. Learn more about FILSPARI projected market size for IgAN @ FILSPARI IgA Nephropathy IgA nephropathy (IgAN) is an autoimmune disorder that disrupts kidney function by damaging the small blood vessels responsible for filtration. This damage is caused by an abnormal protein that harms the glomeruli, the kidneys' main filtering units. According to DelveInsight, there were approximately 415,000 diagnosed prevalent cases of IgAN across the seven major markets in 2024, and this number is projected to grow at a CAGR of 0.6% through 2034. Current standard care involves the use of ACE inhibitors and angiotensin II receptor blockers (ARBs), primarily to manage associated symptoms like hypertension. Currently, only a few drugs have been approved for IgAN treatment, including VANRAFIA (Atrasentan) and FABHALTA (Iptacopan) by Novartis, FILSPARI (Sparsentan) by Travere Therapeutics, and TARPEYO/KINPEYGO (budesonide) by Asahi Kasei (Calliditas Therapeutics), among others. The treatment landscape is expected to undergo major changes between 2024 and 2034, driven by the introduction of innovative therapies. DelveInsight estimates the IgAN market across the seven key regions was valued at around USD 730 million in 2024 and is projected to grow at a strong CAGR of 30.5% from 2025 to 2034. With targeted treatment options for IgAN only recently emerging and a pressing need for therapies that can delay progression to end-stage kidney disease (ESKD), significant advancements in this area are likely to profoundly reshape the market in the coming years. Discover more about the IgAN market in detail @ IgA Nephropathy Market Assessment Emerging Competitors of FILSPARI Key companies advancing therapies for IgA nephropathy include Novartis (Zigakibart/FUB523), F. Hoffmann-La Roche and Ionis Pharmaceuticals (Sefaxersen/RG6299/IONIS-FB-LRx), AstraZeneca's Alexion Pharmaceuticals (ULTOMIRIS), Vera Therapeutics (Atacicept), Vertex Pharmaceuticals (Povetacicept), Otsuka Pharmaceutical (Sibeprenlimab), Biogen (Felzartamab), Arrowhead Pharmaceuticals (ARO-C3), NovelMed (NM8074), Q32 Bio (ADX-097), Walden Biosciences (WAL0921), and Takeda Pharmaceutical (TAK-079), among others. In April 2025, Vera Therapeutics announced it had completed patient enrollment for its pivotal Phase III ORIGIN trial assessing atacicept in IgA nephropathy. The previous month, Otsuka Pharmaceutical submitted a Biologics License Application (BLA) to the FDA for sibeprenlimab, a monoclonal antibody aimed at inhibiting APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. Additionally, in July 2022, the European Commission granted Orphan Drug Designation (ODD) to BION-1301 for primary IgAN, offering regulatory benefits to support its European development. Strengthening its renal pipeline, Novartis acquired Chinook Therapeutics in August 2023 for up to $3.5 billion, adding zigakibart and other late-stage kidney-focused assets to its portfolio. To know how does FILSPARI compare to other treatments for IgA nephropathy, visit @ FILSPARI Approval Date Key Milestones of FILSPARI In November 2024, FILSPARI was approved by the MHRA for primary IgAN treatment, and sparsentan received approval in Germany for the same indication. In September 2024, the FDA granted full approval for FILSPARI to slow kidney function decline in IgAN patients, based on positive long-term results from the PROTECT Study. In April 2024, CSL Vifor and Travere Therapeutics received Conditional Marketing Authorization (CMA) from the European Commission for FILSPARI in the EU, targeting adults with IgAN and significant proteinuria. In February 2023, the US FDA granted accelerated approval to FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid progression, with priority review. Discover how FILSPARI is shaping the IgAN treatment landscape @ FILSPARI IgAN FILSPARI Market Dynamics FILSPARI, developed by Travere Therapeutics, represents a significant advancement in the treatment of IgA Nephropathy, a rare and chronic autoimmune kidney disease. Approved under the FDA's accelerated approval program in early 2023, FILSPARI is the first non-immunosuppressive therapy specifically targeting proteinuria in IgAN. It is a dual endothelin angiotensin receptor antagonist (DEARA), a novel mechanism that distinguishes it from conventional RAAS inhibitors. Its market entry has been notable for both its scientific innovation and potential to reshape the standard of care for IgAN, particularly in patients at high risk of progression to end-stage kidney disease (ESKD). The market dynamics are influenced by multiple factors, including the unmet need in IgAN, the orphan drug designation, and the limited competition in the space. Prior to FILSPARI's launch, treatment was largely supportive, focusing on blood pressure control and proteinuria reduction via ACE inhibitors or ARBs. FILSPARI's ability to deliver greater proteinuria reduction without the side effects associated with corticosteroids or immunosuppressants provides a compelling clinical and commercial value proposition. Competition is evolving, with several companies advancing novel IgAN therapeutics. Calliditas Therapeutics' TARPEYO (budesonide) was approved ahead of FILSPARI for a similar indication, but works through a corticosteroid pathway. Other players are also advancing programs, suggesting the market could become more segmented based on patient profile and mechanism of action. FILSPARI's differentiated profile, especially its dual-acting mechanism and oral administration, positions it favorably among nephrologists and specialists, but maintaining this edge will require strong real-world evidence and ongoing clinical data. From a market access and adoption standpoint, Travere has made early efforts in physician education, patient support programs, and collaboration with nephrology groups to accelerate uptake. However, broader adoption will depend on securing favorable formulary placements, long-term safety data, and sustained efficacy in delaying disease progression. As I gAN awareness grows and diagnosis rates improve through genetic and biomarker testing, the addressable patient population may expand, offering a significant growth opportunity for FILSPARI over the next 5–10 years. Dive deeper to get more insight into FILSPARI's strengths & weaknesses relative to competitors @ FILSPARI MoA Table of Contents Related Reports IgA Nephropathy Market IgA Nephropathy Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key IgAN companies such as Calliditas Therapeutics AB, Travere Therapeutics, Inc., Omeros, Novartis Pharmaceuticals, Chinook Therapeutics, Inc., Vera Therapeutics, Inc., among others. IgA Nephropathy Pipeline IgA Nephropathy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key IgA nephropathy companies, including Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., Vera Therapeutics, Inc., Eledon Pharmaceuticals, Guangdong Hengrui Pharmaceutical Co., Ltd, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Rohto Pharmaceutical, Alexion Pharmaceuticals, Apellis Pharmaceuticals, Inc., Arrowhead Pharmaceuticals, Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, among others. Chronic Kidney Disease Market Chronic Kidney Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic kidney disease companies, including ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc, Lexicon Pharmaceuticals, Sanofi , among others. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key chronic kidney disease companies, including KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3 NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4 ST. GALLEN, Switzerland, May 23, 2025 /PRNewswire/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5 What this means in practice is that there is enough evidence to show that sparsentan provides benefits and value for money, so it can be used routinely if it is considered the most suitable treatment option in this population.3 Sparsentan must be funded in England within 90 days of final publication of this guidance3 which is expected to be 27 June 2025. Professor Jonathan Barratt, Professor of Renal Medicine at University Leicester, UK, welcomed the NICE decision as a major advancement in the treatment of IgA nephropathy in the UK. "IgA nephropathy is a condition with an average age at diagnosis of around 40 years.6 Due to disease progression, a patient's kidneys may fail. Treatments, such as sparsentan, that have been developed for IgA nephropathy are urgently needed, our goal being to improve outcomes for these patients." IgA nephropathy is characterised by the buildup of a faulty version of immunoglobulin A (IgA), which accumulates in clusters in small blood vessels in the kidney, called glomeruli, that filter the blood. These clumps damage the glomeruli causing leakage of blood (haematuria) and protein (proteinuria) into the urine resulting in a progressive loss of kidney function. Proteinuria is a major risk factor for IgA nephropathy progression, increasing the risk of kidney failure.6-8 Despite current treatments, some patients with IgA nephropathy do not achieve adequate proteinuria reduction and remain at risk of progression.9 Although classified as rare, IgA nephropathy is the most common type of primary glomerular disease worldwide, with over 22,000 adults estimated to have the condition in England.10 Patients generally face a poor prognosis if the condition is not appropriately controlled, with approximately 30-40% of patients developing kidney failure within 10 years of diagnosis.11 Current medical treatment guidelines by KDIGO (Kidney Disease, Improving Global Outcomes) state that patients who are at high risk of progressive chronic kidney disease, despite maximal supportive care, are those with persistent urine protein excretion >1 g/day.12 Underscoring the importance of the NICE recommendation for IgA nephropathy patients and their communities, Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor said: "We are very pleased that NICE recognised the value of our innovative therapy which helps to address a clear unmet medical need in patients with IgA nephropathy. We look forward to working with the National Health Service to ensure access to this important medicine as soon as possible as we continue to deliver on our promise to patients." CSL Vifor expects to launch sparsentan in the UK in the second half of 2025; commercial stock will be available from July 2025. Notes to Editors On 15th April 2025, the MHRA granted the marketing authorisation for sparsentan based on the final results of the Phase 3 PROTECT double blind study.5 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialise 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, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, cslvifor.com. 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 (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 (accessed May 2025). NKF Kidney Disease Stages (accessed May 2025). NKF Haemodialysis (accessed May 2025). NKF Transplants for All Transplantation (accessed May 2025). Mayo Clinic What is IgA Nephropathy? (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). CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] Job no: UK-SPT-25000110 Date: 23 May 2025 Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED