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

Travere Therapeutics, Inc.

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.