Travere Therapeutics, Inc. (TVTX) announced on Tuesday that it has completed a Type C meeting with the FDA regarding its plan to submit an sNDA for FILSPARI for the treatment of focal segmental glomerulosclerosis.
Focal Segmental Glomerulosclerosis or FSGS, a leading cause of kidney failure, currently has no approved pharmacological treatments.
FILSPARI, a potential treatment for this rare kidney disorder, is poised to become the first and only approved medication for FSGS, if approved. The sNDA will be based on data from the Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrate the drug's effectiveness in addressing proteinuria — a key marker in FSGS progression.
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