Travere Therapeutics Submits SNDA Seeking Full Approval Of Filspari In IgA Nephropathy

(RTTNews) - Travere Therapeutics, Inc. (TVTX) Monday said it has submitted supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) seeking full approval of Filspari for the treatment of IgA nephropathy (IgAN), a chronic kidney disease.

In February last year, the FDA had granted accelerated approval to Filspari to reduce protein in the urine (proteinuria) in adults with IgAN.

Phase 3 PROTECT Study had shown that Filspari demonstrated long-term kidney function preservation and achieved a significant reduction in proteinuria versus an active comparator.