Supplemental NDA submitted to the FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy

In February 2023, the FDA granted accelerated approval to Filspari as the first and only non-immunosuppressive treatment targeting glomerular injury in the kidney to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The sNDA is based on 2-year confirmatory results from the Phase III PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

“Since being introduced under accelerated approval, Filspari has positively impacted the lives of many people living with IgAN. The submission of the sNDA is an important step toward potentially gaining full approval in IgAN in support of reaching more people living with this devastating rare kidney disease,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Filspari is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis. The results from the pivotal Phase III PROTECT Study show that by directly targeting glomerular injury in the kidney with Filspari, patients can achieve sustained proteinuria reduction and long-term kidney function preservation. We look forward to working with the FDA throughout the upcoming review process.”

Filsapri is a once-daily, oral medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II). Filspari is also the first and only non-immunosuppressive therapy approved for the treatment of this rare kidney disease. The sNDA submission is supported by results from the Phase III PROTECT Study that showed that Filspari demonstrated long-term kidney function preservation and achieved a significant reduction in proteinuria and a clinically meaningful difference in eGFR slope versus an active comparator.

The FDA has 60 days from the receipt of the application to determine whether to accept it for review. The Company expects to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in the second quarter of 2024.

In addition to the sNDA submission to the FDA, the Company and its European commercial partner CSL Vifor recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe. A decision by the European Commission is expected in the second quarter of 2024. If approved, sparsentan would receive a CMA in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway.