Travere Therapeutics has received full approval from the US Food and Drug Administration (FDA) for Filspari (sparsentan) to slow the decline of kidney function in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.
Filspari is the only oral, once-daily, non-immunosuppressive medication designed to directly address glomerular injury in the kidney. It targets two key pathways involved in IgA nephropathy (IgAN) disease progression.
The drug initially received accelerated approval in February 2023 based on the surrogate marker of proteinuria.
In April 2024, Travere Therapeutics and CSL Vifor secured conditional marketing authorisation from the European Commission for Filspari to treat IgAN.
The conversion to full approval in the US is based on positive long-term results from the Phase 2 PROTECT Study.
The global, randomised, multicentre, double-blind, parallel-arm, active-controlled clinical trial assessed the safety and efficacy of 400mg of Filspari against 300mg of irbesartan.
The study involved 404 patients aged 18 and older with IgAN and persistent proteinuria despite treatment.
According to the results, Filspari significantly slowed kidney function decline over a two-year period compared to irbesartan.
The trial met its pre-specified primary endpoint, demonstrating that after 36 weeks, patients treated with the drug experienced a mean reduction in proteinuria of 49.8% from baseline.
In contrast, patients receiving irbesartan had a mean reduction of 15.1% from baseline.
The drug was also well tolerated and demonstrated a clearly defined safety profile that has remained consistent across all clinical trials conducted so far.
Travere Therapeutics president and CEO Eric Dube said: “We know that most people living with IgAN are at risk of disease progression and are seeking a safe, effective and convenient treatment option that can help preserve their kidney function.
“Full approval now enables physicians to confidently prescribe Filspari more broadly as a once-daily, oral, non-immunosuppressive treatment, that can provide superior preservation of kidney function and replace current standard of care.”
After discussions with the FDA, the biopharmaceutical company plans to submit a supplemental New Drug Application (sNDA) to potentially modify the liver-monitoring Risk Evaluation and Mitigation Strategy (REMS).
Last December, Calliditas Therapeutics received FDA’s full approval for Tarpeyo (budesonide) in primary IgAN treatment.
