Travere , CSL Vifor announce Sparsentan received positive CHMP opinion

Travere Therapeutics and CSL Vifor announced that the European Medicines Agency’s, EMA, CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy with a urine protein excretion greater than1.0 g/day. 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 positive recommendation from the CHMP represents a significant advancement toward the delivery of new treatment options for people living with IgAN in Europe, who face the risk of progression to kidney failure and who currently have no approved non-immunosuppressive treatment options. 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.”