Travere Therapeutics completes pre-NDA meeting with the FDA for Filspari

Travere Therapeutics announced the completion of a pre-NDA meeting with the FDA for Filspari in IgA nephropathy, or IgAN. The company will submit a supplemental new drug application, or 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, or 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, or 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, 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 launch and clinical development of pegtibatinase; this action is expected to extend our cash runway into 2028. We have not taken this decision lightly and we are grateful to all of our colleagues who have contributed tremendously to furthering our mission and dedication to helping people living with a rare disease. We are committed to supporting our colleagues who are affected through this challenging time.” Following supportive FDA feedback on the company’s plan to submit the two-year results from the Phase 3 PROTECT Study in IgAN, Travere to submit sNDA in Q1 2024 for full U.S. approval of Filspari in IgAN.