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Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy
First non-immunosuppressive therapy for the treatment of IgA nephropathy (IgAN) approved in Europe Conditional marketing authorization is based on
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"First non-immunosuppressive therapy for the treatment of IgA nephropathy (IgAN) approved in Europe Conditional marketing authorization is based on statistically significant and clinically meaningful results from the Phase 3 PROTECT Study SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- 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 Jürgen 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 fo...