USFDAApr 14, 2026, 07:02 AM
Ligand's FILSPARI gets FDA approval for FSGS; expands market
AI Summary
Ligand Pharmaceuticals announced that its partner Travere Therapeutics received FDA approval for FILSPARI (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. This approval expands FILSPARI's indication beyond IgA nephropathy into a second rare kidney disease, making it the first and only FDA-approved medicine for FSGS. Ligand is entitled to a 9% royalty on worldwide net sales of FILSPARI, which is expected to be a key driver of long-term royalty growth, targeting an addressable U.S. population of over 30,000 individuals.
Key Highlights
- FILSPARI received FDA approval for focal segmental glomerulosclerosis (FSGS) in patients 8+ without nephrotic syndrome.
- Ligand Pharmaceuticals is entitled to a 9% royalty on worldwide net sales of FILSPARI.
- The estimated addressable U.S. population for FSGS without nephrotic syndrome is over 30,000 individuals.
- FILSPARI demonstrated a statistically significant 46% reduction in proteinuria in the DUPLEX study.
- FILSPARI is the first and only FDA-approved medicine for FSGS.