The U.S. Food and Drug Administration (FDA) has approved the updated Risk Evaluation and Mitigation Strategy (REMS) for Filspari (sparsentan) for the treatment of IgA nephropathy (IgAN).
IgAN is a rare disorder that occurs when IgA accumulates in the kidneys. In the early stages, IgAN has no symptoms. The first sign of this condition may be blood in the urine. If left untreated, end-stage kidney disease may develop. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgAN, such as cirrhosis of the liver, celiac disease, and HIV infection.
Sparsentan is the only dual endothelin angiotensin receptor antagonist approved for IgAN. The updated REMS reduces the frequency of liver function monitoring required from monthly to every three months from treatment onset. It also removes the embryo-fetal toxicity monitoring requirement.
This update was supported by safety data from post-marketing surveillance and the phase 3 PROTECT study, the phase 3 DUPLEX study, and the phase 2 DUET study in focal segmental glomerulosclerosis (FSGS). FSGS is a kidney disorder characterized by scar tissue that forms in some of the glomeruli in the kidney. FSGS may cause non-specific signs and symptoms, including protein in the urine, elevated levels of creatinine, and swelling.
A supplemental New Drug Application for sparsentan in FSGS is currently under FDA review with a Prescription Drug User Fee Act (PDUFA) target action data of January 13, 2026. Stay up to date on upcoming PDUFA dates, visit https://checkrare.com/2025-orphan-drugs-pdufa-dates-and-fda-approvals/.
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