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Travere Therapeutics Submits New Drug Application for Sparsentan for the Treatment of IgA Nephropathy
SAN DIEGO, March 21, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that it has submitted a New Drug Application (NDA) to
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, March 21, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN). “There is a clear need for novel treatment options that can reduce proteinuria and slow the devastating progression towards end-stage kidney disease for people living with IgA nephropathy,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “The submission of this NDA marks an important milestone on our path to potentially making sparsentan, if approved, a new treatment standard for the rare kidney disease community, and we look forward to working with the FDA during the upcoming review process.” The NDA submission is supported by positive interim results from the ongoing pivotal Phase 3 PROTECT Study, a global, randomized, active-controlled study evaluating the safety and efficacy of sparsentan in a total of 404 patients with IgAN, as well as data from additional clinical trials and pre-clinical testing of sparsentan. The Company expects to receive notice regarding the acceptance of the NDA, as well as the timeline for NDA review, from the FDA in May 2022. About IgA Nephropathy IgA nephropathy (IgAN), also called Berger's disease, is a rare kidney disorder 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), and protein in the urine (proteinuria). Other symptoms of IgAN may include kidney pain, swelling (edema) and high blood pressure. IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of end-stage kidney disease (ESKD). IgAN is estimated to affect more than 100,000 people in the U.S. and is one of the leading causes of acute nephritis in Europe and Japan. There are currently no approved non-immunosuppressive treatments indicated for IgAN. About the PROTECT Study The ongoing PROTECT Study is one of the largest interventional studies to date in IgAN. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the s...