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Highlights
- FILSPARI® suggested IgA Nephropathy patients are at risk of progressive kidney function loss.
- PROTECT study shows FILSPARI reduces proteinuria by 49.8% compared to 15.1% with irbesartan.
- FILSPARI now approved and launched in the U.S. and selected European countries.
CSL Vifor and Travere Therapeutics (NASDAQ:TVTX) announced support for the updated 2025 KDIGO clinical practice guideline for the management of IgA Nephropathy (IgAN) and IgA vasculitis. The guidelines define diagnostic criteria, treatment goals, and approaches for clinicians and patients managing IgAN.
The update highlights remission of proteinuria (<0.5 g/day, ideally <0.3 g/day) and slowing eGFR decline as key treatment objectives. To achieve these goals, therapies targeting both IgAN-induced nephron loss and IgA formation are recommended.
FILSPARI®, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is recognized in the guidelines as a potential first-line therapy for IgAN, in contrast to the traditional RASi-first approach. The guidelines note FILSPARI as the only therapy with demonstrated efficacy versus optimized RASi in clinical trials, with the PROTECT study enrolling more patients than all prior RASi trials combined.
The PROTECT Study is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 trial in 404 IgAN patients. Patients receiving FILSPARI (n=202) showed a mean reduction in proteinuria from baseline of 49.8% at 36 weeks, compared to 15.1% for irbesartan (n=202, p<0.0001). Two-year follow-up showed FILSPARI reduced the rate of kidney function decline versus irbesartan. Treatment-emergent adverse events were generally balanced, with dizziness and hypotension reported more frequently with FILSPARI.
FILSPARI is a non-immunosuppressive therapy approved in the U.S. and Europe, and launched in Germany, Austria, Switzerland, Luxembourg, and the UK.
