Travere Therapeutics FILSPARI® sNDA Accepted by FDA for FSGS Treatment
Friday, May 16, 2025
Travere Therapeutics, Inc. has announced that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).
FSGS is a rare kidney disorder that often leads to kidney failure. It affects both children and adults and is marked by protein leakage into the urine due to damage to the kidney's filtering units. This leakage can lead to further kidney damage. It is estimated that over 40,000 people in the United States are affected by FSGS, with similar numbers in Europe. There are currently no approved pharmacological treatments specifically for FSGS.
FILSPARI is an oral, non-immunosuppressive therapy that blocks both the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R), which are involved in podocyte injury – a key feature of FSGS. It is already approved to slow the progression of kidney damage in adults with IgA nephropathy.
The application seeks traditional approval of the treatment and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of 13 January 2026. The FDA has also indicated plans to hold an advisory committee meeting to review the application.
The sNDA submission is supported by data from the Phase 3 DUPLEX study and the Phase 2 DUET study. These are among the most comprehensive interventional studies carried out to date in FSGS, involving both adult and paediatric patients.
Results from these studies demonstrated that FILSPARI led to rapid and sustained reductions in proteinuria compared to irbesartan, a commonly used treatment. The safety profile of FILSPARI was comparable to that of irbesartan, with no new safety concerns reported.
Patients completing the blinded phases of the DUPLEX and DUET studies were given the opportunity to join an open-label extension.
Travere’s progress with FILSPARI represents a potential new option for people living with FSGS, a condition for which there are currently no approved targeted therapies.
Source: travere.com
