Travere Therapeutics Scores Accelerated FDA Approval For Rare Kidney Disease Treatment - Travere Therapeutics (NASDAQ:TVTX)

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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