The US Food and Drug Administration (FDA) has approved Filspari (sparsentan) to reduce proteinuria in patients with focal segmental glomerulosclerosis (FSGS). The indication includes adult and pediatric patients ages 8 years and older without nephrotic syndrome.
In the clip below, Howard Trachtman, MD, of the University of Michigan, discusses FSGS and the clinical data that led to sparsentan’s approval.
FSGS is a rare kidney disorder characterized by scar tissue that forms in the glomeruli. Signs and symptoms include protein in the urine, elevated levels of creatinine, and swelling. In many cases the cause can not be determined. Some cases are thought to be associated with congenital kidney defects, urine backing up into the kidneys, obesity, obstructive sleep apnea, sickle cell anemia, or viruses.
Sparsentan is a dual endothelin and angiotensin II receptor antagonist that reduces kidney inflammation and proteinuria. It was originally approved for the treatment of IgA nephropathy and is now the first and only medicine approved by the FDA for the treatment of FSGS.
The approval is based on results from the phase 3, global, randomized, multicenter, double-blind, parallel-arm, active-controlled DUPLEX clinical trial (NCT03493685). The trial enrolled 371 patients ages 8 to 75 years with FSGS.
Patients treated with sparsentan in the overall study population experienced a statistically significant reduction of 46% in proteinuria from baseline to week 108, compared to 30% in patients treated with maximum labeled dose irbesartan. In patients without nephrotic syndrome, a 48% reduction in proteinuria from baseline to week 108 was observed, compared to 27% in those treated with irbesartan. Additionally, patients treated with sparsentan demonstrated a benefit in estimated glomerular filtration rate (eGFR) with a treatment difference of 1.1 mL/min/1.73 m^2 based on mean change from baseline to week 108.
Across both adult and pediatric patients, sparsentan was generally well tolerated, with a safety profile comparable to irbesartan and consistent across clinical programs.
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To learn more about FSGS and other rare kidney conditions, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/