CHMP positive opinion for Filspari (sparsentan) for the treatment of IgA nephropathy.-Travere Therapeutics, Inc., + CSL Vifor.
Travere Therapeutics, Inc. and CSL Vifor announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of Filspari (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion greater than 1.0 g/day (or urine protein-to-creatinine ratio greater than 0.75 g/g)
IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.
The PROTECT Study is the only head-to-head study in IgAN against a maximally labeled dose of irbesartan, a current standard of care .
The study demonstrated treatment with sparsentan resulted in a rapid and sustained reduction in proteinuria and has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgAN,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Together with CSL Vifor, we look forward to the European Commission’s decision in the second quarter of 2024.”
The positive CHMP opinion is based on results from the pivotal Phase III PROTECT Study of sparsentan in IgAN.
In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for Conditional Marketing Authorization to the EMA. The European Commission previously granted Orphan Medicinal Product Designation to sparsentan for the treatment of IgAN.
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