Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

Core Viewpoint - Travere Therapeutics received full FDA approval for its oral nonimmunosuppressive drug Filspari (sparsentan) for the treatment of IgA nephropathy (IgAN), marking it as the only nonimmunosuppressive medication in this space [1] Company Summary - Filspari was initially granted accelerated approval in February 2023 to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression [2] - Following the full approval, Filspari's label expansion allows treatment for a broader patient population, including those at lower risk of disease progression [3] - Travere's shares increased nearly 11% after the announcement, with a year-to-date stock increase of 22.1%, contrasting with the industry's 2.8% decline [3] Clinical Study Insights - The approval was based on the pivotal phase III PROTECT study, which showed that Filspari preserved long-term kidney function compared to irbesartan [5] - The modified intention to treat (ITT) analysis included all patients, even those who stopped treatment, which was favored by the FDA [6] - The PROTECT study achieved a mean eGFR slope of -3.0 mL/min/1.73 m/year for Filspari compared to -4.2 mL/min/1.73 m/year for irbesartan [8] Regulatory and Safety Considerations - Filspari is included in the FDA's Risk Evaluation and Mitigation Strategies (REMS) program, requiring monitoring of liver enzymes before and during treatment [9] - The drug carries a boxed warning for severe birth defects if taken during pregnancy [10] Competitive Landscape - Calliditas Therapeutics dominates the IgAN space with its drug Tarpeyo, which received full FDA approval in December 2023 [11] - Novartis entered the IgAN market with the accelerated approval of Fabhalta for reducing proteinuria, marking its first FDA approval in the renal pipeline [13] - Novartis is also developing additional candidates in the IgAN indication, including atrasentan and zigakibart, following its acquisition of Chinook Therapeutics [14]