Travere Therapeutics

FDA grants full approval to Travere Therapeutics’ Filspari (sparsentan) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN), supported by phase 3 PROTECT study results showing significant kidney function preservation over two years compared to irbesartan.

Tra­vere Ther­a­peu­tics won full ap­proval for Filspari, treating a rare au­toim­mune dis­ease affecting the kid­neys.

The FDA has fully approved sparsentan (Filspari; Travere Therapeutics), an oral, non-immunosuppressive medication that significantly slows kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). The approval is based on the PROTECT study, which showed a 1.2 mL/min/1.73m²/year treatment effect over 2 years compared to irbesartan. Sparsentan is well-tolerated and offers a superior option for preserving kidney function.

FDA grants full approval to Filspari® (sparsentan) for slowing kidney function decline in adults with IgA nephropathy at risk of progression. The approval is based on the PROTECT trial's final analysis, showing sparsentan reduced the rate of kidney function decline compared to irbesartan, with a treatment effect of 1.2 mL/min/1.73m² per year.

Travere Therapeutics' stock surged after FDA full approval for kidney disease treatment Filspari, expanding market potential to over 70,000 IgA patients in the U.S. and raising peak sales estimates to $661 million. The approval aligns with Calliditas Therapeutics' similar FDA approval for Tarpeyo in December 2023.

Travere Therapeutics receives FDA full approval for Filspari (sparsentan) to slow kidney function decline in IgAN patients. Filspari is an oral, once-daily, non-immunosuppressive medication targeting two key pathways in IgAN progression. The approval is based on the Phase 2 PROTECT Study results showing significant kidney function preservation compared to irbesartan.

FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.

The FDA granted full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, removing the UPCR requirement. The approval includes boxed warnings for hepatotoxicity and birth defects, necessitating a REMS program and regular kidney function monitoring. Despite earlier data requests for FSGS treatment, the approval is based on the PROTECT trial's modified analysis showing Filspari's efficacy in slowing kidney function decline.

FDA grants full approval to Filspari, a daily oral, non-immunosuppressive medication, to slow kidney function decline in adults with primary IgA nephropathy. The approval is based on the phase 3 PROTECT study, which showed that Filspari significantly slowed kidney function decline compared to irbesartan.