Business
Travere Therapeutics and CSL Vifor Announce EMA has Accepted for Review the Conditional Marketing Authorization Application for Sparsentan for the Treatment of IgA Nephropathy
A review decision by the European Medicines Agency (EMA) is expected in the second half of 2023 If approved, sparsentan will be a first-in-class treatment to
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"A review decision by the European Medicines Agency (EMA) is expected in the second half of 2023 If approved, sparsentan will be a first-in-class treatment to address the significant unmet medical need in IgA nephropathy (IgAN) in Europe SAN DIEGO and ST. GALLEN, Switzerland, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and CSL Vifor today announced that the EMA has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and leading cause of end-stage kidney disease (ESKD). The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023. “Following U.S. FDA’s acceptance and granting of priority review of the NDA for sparsentan for IgA nephropathy in the U.S., we continue to make great progress towards our goal of enabling sparsentan to become a new treatment standard for rare kidney disorders, if approved,” said Jula Inrig, M.D. chief medical officer of Travere Therapeutics. “The acceptance of the CMA application marks an important next step on our pathway to expanding access to sparsentan as the first non-immunosuppressive treatment option for IgA nephropathy in Europe, if approved. We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.” “The acceptance of the EU regulatory application for sparsentan marks a major milestone towards our goal of bringing this first-in-class therapy to the patients suffering from IgAN, for which there are currently no approved non-immunosuppressive therapies,” commented Klaus Henning Jensen, chief medical officer of CSL Vifor. “We look forward to working closely with our partner, Travere, through the EMA review process with the aim to bring this innovative treatment option to patients living with IgAN in Europe.” The EMA filing is supported by positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgAN, as well as supportive data from additional clinical studies. The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance. After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuri...