Shots:
- The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026)
- sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind phases could then opt for an OLE study
- DUPLEX met FPRE endpoint at 36wks. but did not meet the 1EP of eGFR slope at 108wks., though 2yr. data reported benefits over 108wks., incl. reduced proteinuria & high PR as well as CR rates; data was published in The NEJM, whereas P-II met its 1EP, with over a two-fold proteinuria reduction
Ref: Travere Therapeutics | Image: Travere Therapeutics | Press Release
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