Travere Therapeutics Secures Full FDA Approval for Filspari, Expands Market Potential in IgA Nephropathy

Travere Therapeutics (NASDAQ: TVTX) secured a significant regulatory win on September 5, 2024, with the U.S. Food and Drug Administration (FDA) granting full approval for Filspari (sparsentan) as a treatment to slow kidney function decline in adults with immunoglobulin A nephropathy (IgAN) at risk of disease progression. In February 2023, the FDA granted Filspari accelerated approval, with a specific urine protein level requirement. The new full approval removes the previous requirement, expanding the drug’s potential reach and paving the way for further growth. Filspari stands out as the first non-immunosuppressive treatment for IgAN, a rare autoimmune kidney disease. However, the drug comes with a boxed warning for hepatotoxicity and birth defects, which limits its distribution under the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program.

Visible Alpha consensus forecasts Filspari’s expanded approval for IgAN to be a major revenue driver for Travere Therapeutics, with projected sales of $118 million in 2024, up from $29 million in 2023. Filspari for IgAN is expected to account for about 53% of Travere’s total revenue in 2024. In addition to IgAN, Filspari is in Phase 3 trials for focal segmental glomerulosclerosis (FSGS), a rare kidney condition that can lead to kidney failure. The drug has already received orphan drug designation from the FDA and the European Medicines Agency (EMA) for FSGS. According to Visible Alpha estimates, Filspari could generate $0.7 million in revenue for FSGS in 2025, pending approval. Filspari for IgAN and FSGS together is projected to reach peak global sales of $ 1,005 million by 2033. Overall, Travere experienced a -31% year-over-year revenue decline in 2023, primarily due to the sale of its bile acid product portfolio to Mirum Pharmaceuticals. However, analysts expect a +54% rebound in total revenue in 2024, reaching $224 million.