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Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the First and Only Approved Medicine for FSGS
FILSPARI indicated to reduce proteinuria in adults and children aged 8 years and older with FSGS who do not have nephrotic syndrome Additional indication for
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"\nFILSPARI indicated to reduce proteinuria in adults and children aged 8 years and older with FSGS who do not have nephrotic syndrome\n\n\nAdditional indication for FILSPARI expands total addressable population to more than 100,000 patients in the U.S, including more than 30,000 patients with FSGS\n\n\nLabel aligns with KDIGO clinical practice guidelines for managing patients with FSGS\n\n\nCompany to host conference call April 13, 2026, at 6:45 p.m. ET\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nTravere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved FILSPARI® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. FILSPARI is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. FILSPARI is currently the most commonly prescribed FDA-approved medicine for IgAN.\n\n\nPeople with FSGS who do not have nephrotic syndrome span across types of FSGS and represent a population aligned with the KDIGO guidelines for treating glomerular diseases. Nephrotic syndrome is commonly defined as the presence of three concurrent criteria: proteinuria greater than 3.5 g/24h, edema, and albumin less than 3.0 g/dL. The company estimates that the addressable population in the U.S. is more than 30,000 individuals with FSGS who do not have nephrotic syndrome.\n\n\n“Today marks a historic milestone for people living with FSGS, who for the first time have an FDA-approved medicine for this rare and devastating condition,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “This approval reflects years of perseverance and our belief that those living with FSGS deserve better. It also builds on our leadership and progress in rare kidney diseases, expanding FILSPARI’s potential reach to more than 100,000 people in the U.S. with FSGS and IgAN who need better treatment options. FILSPARI will be available for nephrologists to immediately prescribe to individuals with FSGS. We are profoundly grateful to the patients, caregivers, investigators, healthcare providers, regulators and advocates who made this moment possible.”\n\n\nIn the Phase 3 DUPLEX Study, the l...