FDA grants accelerated approval to Travere's FILSPARI for IgA nephropathy

Travere Therapeutics, Inc.

FDA approved FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid progression; continued approval contingent on confirmatory data.
FILSPARI showed 45% mean reduction in proteinuria vs 15% for irbesartan in post-hoc sensitivity analysis (label data).
Travere expects to pay $23M milestone to Ligand and BMS in Q1 2023 due to approval.
Topline confirmatory endpoint results from PROTECT Study expected Q4 2023; DUPLEX FSGS results expected Q2 2023.
FILSPARI to be available week of Feb 27, 2023; estimated addressable US patients 30,000-50,000.

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