sparsentan

FDA Drug Profile — FILSPARI

Drug Details

Generic Name
sparsentan
Brand Names
FILSPARI
Application Number
NDA216403
Sponsor
Travere Therapeutics, Inc.
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
SPARSENTAN

Indications and Usage

1 INDICATIONS AND USAGE FILSPARI is an endothelin and angiotensin II receptor antagonist indicated: • To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ). • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2 , 12.1 , 14.2 ). 1.1 Immunoglobulin A Nephropathy FILSPARI is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression [see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.1 )]. 1.2 Focal Segmental Glomerulosclerosis FILSPARI is indicated to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome [see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.2 )].