Travere Therapeutics announced that the FDA has approved FILSPARI® (sparsentan) to reduce proteinuria in adults and children aged 8 years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome.
According to the company, FILSPARI is the first FDA-approved treatment for FSGS, expanding its existing indication beyond IgA nephropathy. The new approval aligns with Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines for managing glomerular diseases. Travere estimates that more than 30,000 people in the United States are affected by FSGS without nephrotic syndrome.
The FDA’s decision was supported by data from the Phase 3 DUPLEX study, which compared FILSPARI to the maximum labeled dose of irbesartan. In the overall study population, FILSPARI achieved a 46% reduction in proteinuria from baseline to week 108, compared with 30% for irbesartan. Among patients without nephrotic syndrome, the reduction was 48% versus 27%, respectively. FILSPARI-treated patients in this subgroup also showed an average treatment difference of 1.1 mL/min/1.73 m² in estimated glomerular filtration rate (eGFR) decline compared to irbesartan.
Travere reported that FILSPARI was generally well tolerated across adult and pediatric participants, with a safety profile consistent with previous clinical findings. The company said the new indication extends the medicine’s potential reach to over 100,000 individuals in the U.S. with FSGS or IgA nephropathy.
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