Travere Therapeutics, in collaboration with CSL Vifor, has achieved a milestone as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) exhibiting a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). 

IgAN, a rare kidney disease and a leading cause of kidney failure, currently lacks approved non-immunosuppressive treatment options. If approved by the European Commission, Sparsentan would become the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for IgAN treatment in Europe.

Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics, expressed his optimism about the CHMP's positive recommendation, stating, "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." 

He emphasized the significance of the PROTECT Study, the only head-to-head study in IgAN against a maximally labeled dose of irbesartan, demonstrating that treatment with Sparsentan resulted in a rapid and sustained reduction in proteinuria and has the potential to preserve kidney function, significantly delaying time to kidney failure compared to an active comparator.

Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, echoed Dr. Dube's sentiments, stating, "The positive CHMP opinion for Sparsentan is one step closer to bringing this treatment option to patients in Europe with IgAN, a rare and serious condition that can cause kidney disease."

The positive CHMP opinion is based on results from the pivotal Phase 3 PROTECT Study of Sparsentan in IgAN. Travere Therapeutics and CSL Vifor submitted a Marketing Authorization Application (MAA) for Conditional Marketing Authorization (CMA) to the EMA in August 2022. The European Commission had previously granted Orphan Medicinal Product Designation to Sparsentan for the treatment of IgAN.

If approved, Sparsentan would receive a CMA in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. Sparsentan is currently marketed in the US under the brand name FILSPARI®, having received accelerated approval by the US Food and Drug Administration based on a reduction in proteinuria.

In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for Sparsentan in Europe, Australia, and New Zealand.