SAN DIEGO - Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion 1.0 g/day (or urine protein-to-creatinine ratio 0.75 g/g).
The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
'As the first and only non-immunosuppressive therapy approved for IgAN, we believe FILSPARI offers clinicians the potential for a new foundational treatment for this rare kidney disease, replacing RAAS inhibition,' said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. 'With this approval and the commercial strength and expertise of our partner, CSL Vifor, we look forward to people living with IgAN in Europe gaining access to this important medicine.'
'This is a significant step forward for patients in Europe living with IgAN, a rare and serious condition, and a leading cause of end-stage renal disease,' said Jurgen Floege, M.D., senior professor, Div. Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT Study. 'The approval of this innovative treatment is based on data from the only head-to-head phase 3 clinical trial in IgAN. Adult patients with IgAN who are at high risk of progressing to kidney failure will now have access to a new therapy that significantly reduces proteinuria and slows the progression of kidney disease.'
'The approval by the European Commission is an important milestone for the IgAN community in Europe and underscores our promise to develop and deliver innovative medicines in our areas of focus where there is unmet need,' said Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL. 'We look forward to working with our partners and EU member states to bring this innovative therapy to patients in Europe.'
The European Commission's decision follows the Committee for Medicinal Products for Human Use (CHMP)'s positive opinion in February 2024, based on results from the pivotal Phase 3 PROTECT Study of FILSPARI in IgAN. 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%, compared to a mean reduction in proteinuria from baseline of 15.1% 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.
CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.
In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.
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.
IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the U.S. and is one of the most common glomerular diseases in Europe and Japan.
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 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, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving at least 50% of max label dose and maximally tolerated ACE or ARB therapy. In August 2021, the Company announced the PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance. Based on the pre-specified, primary analyses set, after 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p
TRAVERE THERAPEUTICS, INC. 
