FDA grants full approval to Filspari to slow kidney decline in primary IgA nephropathy
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Key takeaways:
- Filspari was granted accelerated approval in February 2023.
- The drug targets glomerular injury in patients at risk of disease progression.
The FDA granted full approval to Filspari, a daily oral, non-immunosuppressive medication, to slow kidney function decline in adults with primary IgA nephropathy, according to an industry press release.
As Healio previously reported, Filspari (sparsentan, Travere Therapeutics) was granted accelerated approval in February 2023 based on proteinuria as a biomarker. Full approval was based the phase 3 PROTECT study, which demonstrated sparsentan significantly slowed kidney function decline for patients with IgA nephropathy (IgAN) during the course of 2 years compared with irbesartan.
Sparsentan targets glomerular injury in patients at risk of disease progression by blocking endothelin-1 and angiotensin II. Analysis showed the mean eGFR slope from baseline to week 110 was –3 mL/min/1.73 m2 per year for sparsentan and –4.2 mL/min/1.73 m2 per year for irbesartan, highlighting a positive treatment effect on proteinuria during the study period. The drug was well-tolerated and had clearly defined safety profile, according to the release.
“The expanded indication and full approval of Filspari is welcome news for the rare kidney disease community,” Josh Tarnoff, CEO of NephCure, said in the release. “We have waited a long time for a medicine to slow the irreversible kidney damage from IgAN and appreciate Travere’s leadership in championing new endpoints for IgAN that have spurred significant innovation for this rare kidney disease.”
To offer support to patients and providers, Travere’s TotalCare program provides services, assistance and for understanding IgAN, insurance, prescriptions and treatment.
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