Business
CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy
Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN,
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial\nST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI 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). \n\n \n \n \n \n \n \n\n \n\"Swissmedic approval further demonstrates our promise to deliver transformational medicines for patients with serious diseases in our areas of focus,\" said Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL. \"There is a high unmet medical need for a targeted therapy to treat IgAN and we look forward to providing access to this innovative treatment option for the Swiss IgAN community as fast as possible. Thank you to all of the patients who participated in the clinical trials, as well as our partners at Travere, for their dedication to deliver this important regulatory approval in Switzerland.\"\n\"FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, non-immunosuppressive treatment that can provide superior results compared to maximally dosed irbesartan, supporting replacing their RASi,\" said Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics. \"Together with our partner, CSL Vifor, we look forward to people living with IgAN in Switzerland gaining access to this important medicine.\"\nSwissmedic approval was supported by results from the pivotal phase-III PROTECT study of FILSPARI in IgAN and follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization by the European Medicines Agency in April 2024.\nAbout CSL Vifor\nCSL 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 Vi...