FDA Requests For Additional Monitoring For Travere Therapeutics' Sparsentan In Rare Kidney Disease - Travere Therapeutics (NASDAQ:TVTX)

Following late-cycle review interactions with the FDA, Travere Therapeutics Inc TVTX expects the previously assigned Prescription Drug User Fee Act (PDUFA) target action date of November 17 for its sparsentan marketing application for IgA nephropathy to be extended by three months.
IgA nephropathy is a rare kidney disorder and a leading cause of end-stage kidney disease.
As part of its late-cycle review, the FDA has requested that the company update its proposed Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring for sparsentan consistent with certain other approved products in the endothelin receptor antagonist class.
The company anticipates submitting an updated REMS plan in the coming days.
No additional clinical data or studies have been requested for the application review process.
The company said the request for additional monitoring within the REMS came unexpectedly.
In August, FDA indicated that the interim analysis from the ongoing Phase 3 DUPLEX study and the recent limited additional estimated glomerular filtration data might not support sparsentan's accelerated approval in focal segmental glomerulosclerosis, a rare disease affecting the kidney filters.
Price Action: TVTX shares are down 10.20% at $20.83 on the last check Friday.