Travere Gains FDA Approval for FSGS Drug After 46% Proteinuria Drop
Travere Therapeutics won FDA approval for sparsentan to treat FSGS patients aged eight and above without nephrotic syndrome, becoming the first therapy approved for this rare kidney disease. In Phase III DUPLEX, sparsentan cut proteinuria by 46% versus 30% for irbesartan and delivered a 1.1 ml/min/1.73 m2 eGFR improvement.
1. FDA Approval Breakthrough
Travere Therapeutics secured full FDA approval for sparsentan (Filspari) to reduce proteinuria in adult and paediatric patients aged eight and above with focal segmental glomerulosclerosis without nephrotic syndrome. This marks the first approved therapy for FSGS, expanding the drug's indication beyond IgA nephropathy into a second rare kidney condition.
2. Phase III DUPLEX Efficacy Data
In the Phase III DUPLEX study, sparsentan achieved a 46% reduction in proteinuria from baseline to week 108 compared to a 30% reduction for irbesartan. In patients without nephrotic syndrome, sparsentan drove a 48% reduction versus 27% for irbesartan and demonstrated a 1.1 ml/min/1.73 m2 mean eGFR advantage over the comparator.
3. Commercial and Market Potential
With over 100,000 US patients affected by FSGS and IgA nephropathy, sparsentan's expanded approval positions Travere to address a significant unmet need in rare kidney diseases. The company plans to make Filspari immediately available to nephrologists, aiming to translate regulatory success into accelerated revenue growth.