Overview
- Filspari (sparsentan) won full FDA approval to lower protein in the urine for adults and children 8 and older with focal segmental glomerulosclerosis who do not have nephrotic syndrome, making it the first approved therapy specific to FSGS.
- In the 108-week Phase 3 DUPLEX trial, Filspari cut proteinuria by 46% from baseline versus 30% with maximum-dose irbesartan across the overall study group.
- Among patients without nephrotic syndrome, the drug reduced proteinuria by 48% versus 27% with irbesartan and showed a small eGFR benefit of about 1.1 mL/min/1.73 m² at week 108.
- Safety was broadly similar to irbesartan in adults and pediatric patients, with common side effects including swelling in the legs and feet, low blood pressure, high potassium, dizziness, and anemia.
- Travere said doctors can prescribe Filspari right away, the approval adds to its prior IgA nephropathy use, analysts noted a broader-than-expected label, and the stock jumped about 44% on Tuesday with targets raised and market value near $2.7 billion.