Latest news about sparsentan/sparsentan 2024

The U.S. Food and Drug Administration (FDA) has given full approval to Sparsentan to slow the decline in kidney function in adults with primary immunoglobulin A (IgA) nephropathy who are at risk for disease progression. Sparsentan is marketed as Filspari and is available in 200 mg and 400 mg tablets.

Sparsentan is an endothelin and angiotensin II receptor antagonist that has previously received accelerated approval for IgA nephropathy based on clinical trial data showing a reduction in proteinuria. Final analysis results from the Phase 3 PROTECT trial support conversion to full approval.

This study evaluated the efficacy and safety of sparsentane in patients with immunoglobulinA nephropathy (IgAN) who have persistent proteinuria and are at high risk of disease progression despite use of stable doses of angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers. Study participants were randomly assigned in a 1:1 ratio to receive once-daily oral sparsentan (n=202) or irbesartan (n=202).

The final analysis showed that treatment with sparsentan reduced the rate of decline in renal function compared with irbesartan. The mean estimated glomerular filtration rate (eGFR) slope from baseline to week 110 was -3.0 mL/min/1.73m2/year for sparsentan and -4.2 mL/min/1.75m2/year for irbesartan, equivalent to a treatment effect of 1.2 mL/min/1.83m2/year (95%CI, 0.2-2.1; P=0.0168).

In the final analysis, a positive treatment effect on proteinuria (based on urine protein/creatinine ratio) was observed at weeks 36 and 110, which was consistent with the results obtained in the interim analysis. Full approval of sparsentan would enable its wider availability as a once-daily oral, non-immunosuppressive treatment that may better protect kidney function.