newsfilter
← Latest News
GlobeNewswire·

Ligand Partner Travere Therapeutics Receives Full FDA Approval for FILSPARI® (sparsentan) in FSGS

LGNDTVTX
  • Ligand Pharmaceuticals announced that partner Travere Therapeutics received FDA approval for FILSPARI (sparsentan) to reduce proteinuria in adults and pediatric patients aged 8+ with FSGS who do not have nephrotic syndrome.
  • FILSPARI is the first & only FDA-approved medicine for this rare kidney disorder, expanding its indication beyond IgA nephropathy to treat FSGS.
  • Ligand is entitled to a 9% royalty on worldwide net sales of FILSPARI for both its IgAN & new FSGS indications.
  • Travere estimates the addressable U.S. population for FSGS without nephrotic syndrome exceeds 30,000 individuals.
  • Phase 3 DUPLEX Study results showed FILSPARI-treated patients without nephrotic syndrome experienced a 48% reduction in proteinuria vs. 27% for irbesartan, with a statistically significant p-value of 0.0075.
  • FILSPARI demonstrated a benefit in eGFR for patients without nephrotic syndrome, showing a mean change of -11.3 mL/min/1.73 m2 compared to -12.4 mL/min/1.73 m2 for irbesartan.
  • The drug utilizes a dual mechanism of action by targeting endothelin A & angiotensin II receptors to reduce kidney inflammation & scarring.
  • FILSPARI was generally well tolerated across both adult & pediatric populations with a safety profile comparable to irbesartan.
  • The DUPLEX Study was a global, randomized, double-blind trial involving 371 patients aged 8 to 75 years, with two-year results published in the New England Journal of Medicine.
  • Ligand expects this approval to serve as a key driver for long-term royalty growth in 2026 & beyond.