Travere Therapeutics Scores Accelerated FDA Approval For Rare Kidney Disease Treatment

  • The FDA granted accelerated approval to Travere Therapeutics Inc's TVTX Filspari (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.
  • It is the first and only non-immunosuppressive therapy approved for this condition. IgAN is a rare kidney disease and causes kidney failure due to glomerular disease.
  • The continued approval of Filspari depends on confirming a clinical benefit in the ongoing Phase 3 PROTECT Study, which is designed to demonstrate whether Filspari slows kidney function decline. 
  • Topline results from the PROTECT Study are expected in Q4 of 2023 and are intended to support the traditional approval of FILSPARI.
  • Interim results from the ongoing Phase 3 PROTECT head-to-head trial demonstrated a rapid, sustained, and clinically meaningful reduction in proteinuria vs. active control, irbesartan.
  • In 2H 2023, Travere Therapeutics and its collaborator CSL Vifor CSLLY anticipate a review decision by the European Medicines Agency for sparsentan.
  • In Q2 2023, the company expects to report topline results from the two-year confirmatory endpoints in the ongoing Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS). Pending supportive data, the company anticipates submitting a supplemental NDA for traditional approval for an FSGS indication in 2H 2023 and by the end of 2023 for European approval.
  • Under a license agreement for sparsentan, Ligand Pharmaceuticals Incorporated LGND is entitled to receive a net $15.3 million milestone on this FDA approval, other potential milestone payments, and net royalties of 9% on future global net product sales of sparsentan.
  • Price Action: TVTX shares are up 1.80% at $18.15 during the premarket session on the last check Tuesday.
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