CSL Vifor together with Travere Therapeutics, Inc., disclosed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) exhibiting significant proteinuria. This recommendation paves the way for a potential conditional marketing authorization (CMA) by the European Commission, positioning sparsentan as a pioneering treatment in Europe for this challenging kidney disorder.

IgA nephropathy, a leading cause of kidney failure, has long challenged healthcare providers due to its complex nature and the absence of non-immunosuppressive treatment options. Sparsentan, with its unique dual-action mechanism as an endothelin angiotensin receptor antagonist, offers hope to patients by potentially slowing disease progression and preserving kidney function.

The CHMP's positive opinion is rooted in the compelling findings from the PROTECT study, a pivotal phase-III clinical trial that demonstrated sparsentan's effectiveness over the current standard of care, irbesartan, in achieving a rapid and sustained reduction in proteinuria. Moreover, sparsentan has shown promise in significantly delaying the onset of kidney failure, suggesting a long-term benefit for patients suffering from IgAN.

"We are thrilled with the CHMP's recommendation, which moves us one step closer to providing a novel treatment option for European patients battling IgA nephropathy," expressed Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL. "Our anticipation for the European Commission's decision in Q2 2024 is high as we continue to fulfill our commitment to delivering innovative solutions for kidney disease."

Eric Dube, Ph.D., President and CEO of Travere Therapeutics, echoed this sentiment, emphasizing the significance of offering a new treatment pathway for those at risk of advancing to kidney failure. "The PROTECT Study's results not only highlight sparsentan's potential to alter the treatment landscape for IgAN but also reinforce our dedication to addressing the unmet needs within this patient community."

In anticipation of the European Commission's final decision, the partnership between CSL Vifor and Travere Therapeutics marks a pivotal step towards enhancing the standard of care for patients with IgAN. This collaboration underscores a shared vision of transforming patient outcomes through innovative therapies.

Sparsentan, already granted accelerated approval in the U.S. under the name FILSPARI® based on its proteinuria reduction capabilities, signifies a beacon of hope for countless patients globally. With exclusive commercialization rights in Europe, Australia, and New Zealand granted to CSL Vifor, the potential approval of sparsentan in Europe will not only broaden its accessibility but also affirm its role as a crucial advancement in the fight against kidney disease.