Travere Therapeutics (TVTX) announced the Company has completed its Type C meeting with the U.S. Food and Drug Administration and plans to submit a supplemental New Drug Application seeking traditional approval of FILSPARI for focal segmental glomerulosclerosis. The sNDA will be based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI and is expected to be submitted around the end of the first quarter of 2025. The Type C meeting follows the recent public workshop led by the PARASOL workgroup. The principal finding from PARASOL was that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure, and responder definitions based on thresholds of proteinuria are both biologically plausible and strongly supported by epidemiological data.
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