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Travere Therapeutics Provides Regulatory Update on its Sparsentan Program for IgA Nephropathy
Conference call and webcast to be held at 4:30p.m. ET SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"Conference call and webcast to be held at 4:30p.m. ET SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that following late-cycle review interactions with the U.S. Food and Drug Administration (FDA), the Company expects the previously assigned Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022 for its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy to be extended by three months. As part of its late-cycle review, the FDA has requested that the Company update its proposed Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring for sparsentan consistent with certain other approved products in the endothelin receptor antagonist class. The Company anticipates submitting an updated REMS plan in the coming days. Based upon feedback from the FDA, the updated submission is likely to be considered a major amendment to the NDA which is expected to result in a three-month extension of the PDUFA target action date to allow sufficient time to review the information. No additional clinical data or studies have been requested as part of the application review process. “While this request for additional monitoring within the REMS came unexpectedly, the strength of the clinical data supporting the profile of sparsentan and our confidence in the potential for sparsentan to be approved as a new therapy for IgA nephropathy remain unchanged,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Many people living with IgA nephropathy continue to face a progression of disease with no currently approved non-immunosuppressive treatments available. We will use the additional time to work collaboratively with the FDA as we continue the labeling process, and further prepare for launch with the goal of enabling sparsentan to ultimately become a new treatment standard, if approved.” Conference Call Information Travere Therapeutics will host a conference call and webcast today, October 13, 2022 at 4:30 p.m. ET to discuss the regulatory update. To participate in the conference call, dial +1-888-254-3590 (U.S.) or +1-929-477-0402 (International), confirmation code 4001801 shortly before 4:30 p.m. ET. The webcast can be accessed at travere.com, in the Events and P...