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Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS
After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgAN to full approval Following engagement with the FDA on the two-year results from the Phase 3 DUPLEX Study in FSGS, Company conducting additional analyses of FSGS data and plans to re-engage FDA in 2024 Company is implementing a strategic reorganization to further focus near-term resources on ongoing FILSPARI launch in IgAN and advancement of pegtibatinase in classical HCU, extending expected cash runway into 2028 SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval. The Company also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS) in which the FDA communicated that the Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission for an FSGS indication for sparsentan. As a result, the Company will be conducting additional analyses of FSGS data with plans to re-engage FDA in 2024, and is implementing a strategic reorganization in Q4 2023 to focus near-term resources on the ongoing FILSPARI launch in IgAN and the advancement of pegtibatinase in classical homocystinuria (HCU). “Following a successful pre-NDA meeting, we are pleased to be moving forward with our planned sNDA submission for full approval of FILSPARI in IgA nephropathy. Our team has been working diligently to prepare a high-quality application which we expect to submit next quarter,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Unfortunately, there is uncertainty around a regulatory path forward for FSGS. While we intend to continue to engage with FDA on a way forward for the more than 40,000 people living with FSGS in the U.S., we must at the same time prioritize our operating expenses. As a result, we have made the difficult decision to reduce our workforce to further focus our resources on the FILSPARI laun...