FDA grants full approval to FILSPARI for FSGS, securing new royalty stream for Ligand

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FDA grants full approval to FILSPARI for FSGS, securing new royalty stream for Ligand
FDA grants full approval to FILSPARI for FSGS, securing new royalty stream for Ligand
Mahathir Bayena
Written by Mahathir Bayena
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Ligand Pharmaceuticals (NASDAQ:LGND) announced on Tuesday, April 14, 2026, that its partner, Travere Therapeutics, has received full U.S. Food and Drug Administration (FDA) approval for FILSPARI (sparsentan).

The approval covers the treatment of proteinuria in both adults and pediatric patients aged eight and older with focal segmental glomerulosclerosis (FSGS) who are at risk of rapid disease progression and do not have nephrotic syndrome.

The regulatory milestone marks a significant expansion for the medication, which was previously granted accelerated approval for IgA nephropathy.

Under the terms of the existing licensing agreement, Ligand is entitled to a 9% royalty on worldwide net sales of the drug.

This approval is expected to provide a sustained long-term revenue boost for Ligand, which operates as a high-margin royalty collector for pharmaceutical innovations.

The FDA’s decision was supported by data from the Phase 3 DUPLEX study, the largest interventional trial ever conducted in FSGS.

The trial demonstrated that FILSPARI achieved a 48% reduction in proteinuria compared to 27% for the active control, irbesartan, in non-nephrotic patients at Week 108.

Furthermore, the therapy showed a clinically significant eGFR benefit of 1.1 mL/min/1.73 m², indicating a preserved level of kidney function over the long term.

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