17.10.2024 13:36:51
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Travere Therapeutics Secures Swiss Authorization For FILSPARI To Treat IgA Nephropathy
(RTTNews) - Travere Therapeutics Inc. (TVTX) and CSL Vifor said that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion greater than or equal to 1.0 g/day or urine protein-to-creatinine ratio greater than or equal to 0.75 g/g.
The approval was supported by results from the pivotal Phase 3 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.
In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.
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