Shots:
- The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome
- Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration to max 800mg sparsentan or 300mg irbesartan
- Trial showed reduced proteinuria by 46% vs 30% with maximum labeled dose irbesartan at Wk. 108, with greater benefit in pts without nephrotic syndrome (48% vs 27%). These pts also showed improved eGFR with a treatment difference of +1.1 mL/min/1.73 m² vs irbesartan (-11.3 vs -12.4 mL/min/1.73 m²)
Ref: Travere | Image: Travere | Press Release
Related News: CSL Vifor and Travere Therapeutics’ Filspari (sparsentan) Gains CHMP’s Positive Opinion to Treat IgA Nephropathy
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
