---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-24-000035"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2024-09-06T23:59:59+00:00"
generated_at: "2026-05-31T06:03:32.381249+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA grants full approval to Travere's FILSPARI for IgA nephropathy based on PROTECT study

## Summary
- FDA full approval for FILSPARI (sparsentan) to slow kidney function decline in adults with primary IgAN at risk of disease progression.
- PROTECT Study: FILSPARI showed mean eGFR slope -3.0 vs -4.2 mL/min/1.73 m2/year for irbesartan (p=0.0168), a 1.2 mL/min/year treatment effect.
- FILSPARI reduced proteinuria by 49.8% vs 15.1% at Week 36 (p<0.0001); effect durable to two years.
- Company plans to submit sNDA for potential modification to liver-monitoring REMS.

## SEC filing metadata
- accession: 0001438533-24-000035
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2024-09-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/0001438533-24-000035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/tvtx-20240905.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-24-000035
- JSON: https://secwatch.observer/filing/0001438533-24-000035.json
- Plain text: https://secwatch.observer/filing/0001438533-24-000035.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.