Travere Therapeutics Receives Approval for Updated REMS Labelling of FILSPARI® in IgA Nephropathy
Thursday, August 28, 2025
Travere Therapeutics has announced that the US Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labelling for FILSPARI® (sparsentan), the only dual endothelin angiotensin receptor antagonist indicated for the treatment of IgA nephropathy (IgAN).
IgA nephropathy (IgAN), also known as Berger’s disease, is a rare progressive kidney disorder caused by the build-up of immunoglobulin A (IgA) in the kidneys. This disrupts normal kidney filtration and can lead to blood in the urine, proteinuria, swelling, high blood pressure, and progressive kidney damage. It is the most common form of primary glomerulonephritis globally and a leading cause of kidney failure, affecting up to 150,000 people in the United States and significant numbers in Europe and Japan.
Focal segmental glomerulosclerosis (FSGS) is a rare condition that causes scarring in the kidneys and affects both adults and children. It is estimated to impact more than 40,000 people in the United States, with similar prevalence in Europe. The condition is marked by proteinuria, which damages kidney function, and can lead to swelling, low blood albumin, abnormal lipid levels, high blood pressure, and eventually kidney failure. Currently, there are no FDA-approved pharmacological treatments for FSGS, and sparsentan is not yet approved for this indication.
The revised guidance reduces the frequency of liver function monitoring from monthly to once every three months, starting from the initiation of treatment. In addition, the requirement for embryo-foetal toxicity monitoring has been removed. These changes are based on safety data from post-marketing surveillance and findings from the Phase 3 PROTECT trial in IgAN, the Phase 3 DUPLEX trial, and the Phase 2 DUET study in focal segmental glomerulosclerosis (FSGS).
The FDA decision to remove the embryo-foetal toxicity monitoring requirement followed an assessment of pregnancy data gathered over the past two decades from the use of endothelin receptor antagonist medicines.
A supplemental New Drug Application (sNDA) for FILSPARI in FSGS is under review, with a Prescription Drug User Fee Act (PDUFA) action date set for 13 January 2026. If approved, FILSPARI would become the first and only therapy available for this condition.
Source: travere.com
