FDA HAS APPROVED FILSPARI™ (SPARSENTAN), THE FIRST-IN-CLASS NON-IMMUNOSUPPRESSIVE THERAPY FOR THE REDUCTION OF PROTEINURIA IN IgA NEPHROPATHY
Travere Therapeutics has received accelerated approval from the US Food and Drug Administration (FDA) for FILSPARI, an oral medication designed to reduce proteinuria in adults with primary IgAN who are at risk of rapid disease progression. FILSPARI is the first non-immunosuppressive therapy approved for this condition, which is a rare kidney disease and a leading cause of kidney failure due to glomerular disease, affecting up to 150,000 people in the US, with around 30,000 to 50,000 of such patients estimated to be addressable under the indication approved via accelerated approval. FILSPARI selectively targets two critical pathways in the disease progression of IgAN - endothelin-1 and angiotensin II. However, the approval of the medication may be contingent upon confirmation of a clinical benefit in the ongoing Phase 3 PROTECT Study, which is designed to demonstrate whether FILSPARI slows kidney function decline. The results from the confirmatory endpoints in the PROTECT Study are expected in the fourth quarter of 2023 and are intended to support traditional approval of FILSPARI. The approval for FILSPARI is granted under accelerated approval based on reduction in proteinuria and it has not been established whether FILSPARI slows kidney function decline in patients with IgAN.
References:
Comments
Post a Comment