#Switzerland #CSL Vifor #Travere Therapeutics #FILSPARI #St. Gallen

CSL Vifor and Travere Therapeutics Celebrate Major Milestone for IgA Nephropathy Treatment

In an exciting development for patients suffering from IgA nephropathy, CSL Vifor and Travere Therapeutics have announced that the European Commission has granted standard marketing authorization for FILSPARI® (sparsentan). This major milestone follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and marks a significant advancement in the treatment landscape for this rare kidney disease.

A Landmark Decision

The European Commission's decision, made public on April 29, 2025, converts conditional marketing approval into standard authorization for FILSPARI, specifically targeting adults with primary IgA nephropathy and a urine protein excretion of at least 1.0 g/day. This approval extends across all European Union member states as well as Norway, Iceland, and Liechtenstein, amplifying access to a much-needed treatment for patients.

Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor, expressed enthusiasm about this decision, emphasizing its importance for patients dealing with IgA nephropathy across Europe. He noted that this approval highlights the robustness of their clinical data and reflects the tireless efforts of his team.

Understanding IgA Nephropathy

IgA nephropathy, also known as Berger's disease, results from the accumulation of immunoglobulin A in the kidneys, leading to symptoms such as blood in the urine, proteinuria, and progressive kidney deterioration. This disease is the most prevalent primary glomerular disorder globally and poses a risk of kidney failure for many affected individuals, with estimates suggesting it impacts up to 250,000 people in Europe, Australia, and New Zealand combined.

The PROTECT Study

The approval for FILSPARI is rooted in comprehensive findings from the pivotal phase-III PROTECT study. This large-scale clinical trial showcased that sparsentan significantly reduced kidney function decline compared to the comparator drug irbesartan over two years. Remarkably, the study fulfilled its primary endpoint, confirming sparsentan's efficacy in slowing down the disease's progression, making it a pioneering Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for this condition.

The results indicated a 49.8% mean reduction in proteinuria for patients treated with FILSPARI versus a mere 15.1% reduction for those on irbesartan, further validating the drug's potential benefits in preserving kidney function.

Commitment to Patients

Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics, reiterated the company's commitment to the IgA nephropathy community, emphasizing that this approval reflects the strength of the PROTECT study data and their dedication to enhancing treatment options for rare kidney diseases. The path ahead includes ongoing collaboration with healthcare professionals and regulatory authorities to ensure that FILSPARI is accessible to those in need.

The Future of FILSPARI

Currently, FILSPARI is already available in Germany, Austria, and Switzerland following its conditional marketing authorization granted in April 2024. The future looks promising, with CSL Vifor holding exclusive commercialization rights in Europe, Australia, and New Zealand.

CSL Vifor continues to position itself as a global leader in nephrology and iron deficiency treatments, while Travere Therapeutics champions the pursuit of innovative therapies for rare diseases. Together, they are paving the way for improved patient outcomes and bringing hope to patients grappling with the challenges of IgA nephropathy.

In conclusion, the transformation of FILSPARI's status from conditional to standard marketing authorization is a crucial step that not only enhances treatment availability but also underscores the commitment of both CSL Vifor and Travere Therapeutics to support and improve the lives of patients affected by chronic kidney conditions.