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, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
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"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 Europe."
The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe," said Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics. "This decision not only validates the strength of the phase-III PROTECT study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN."
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 Europe and is currently available in Germany, Austria and Switzerland, following the European Commission's conditional marketing authorization in April 2024
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, 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 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 (Europe, Australia and New Zealand).
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 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy.
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 UK, Europe and the U.S. FILSPARI is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.
For more information, please refer to the Summary of Product Characteristics (SmPC).
