Travere Therapeutics announces FDA acceptance of sNDA for Filspari

Travere Therapeutics (TVTX) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for traditional approval of FILSPARI for the treatment of focal segmental glomerulosclerosis. The FDA has assigned a Prescription Drug User Fee Act target action date of January 13, 2026, and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application. “Today marks an important milestone in our mission to transform care for patients with rare kidney disease. We are one step closer to potentially delivering the first approved treatment for people living with FSGS – a leading cause of kidney failure and devastating condition that urgently needs new treatment options,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “With this progress, we continue our commitment to the FSGS community who has been waiting so long for an effective medicine. We look forward to the upcoming review process.”