Swissmedic Approves FILSPARI for Treating IgA Nephropathy

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial

ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ — CSL Vifor and Travere Therapeutics, Inc., TVTX today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

“Swissmedic approval further demonstrates our promise to deliver transformational medicines for patients with serious diseases in our areas of focus,” said Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL. “There is a high unmet medical need for a targeted therapy to treat IgAN and we look forward to providing access to this innovative treatment option for the Swiss IgAN community as fast as possible. Thank you to all of the patients who participated in the clinical trials, as well as our partners at Travere, for their dedication to deliver this important regulatory approval in Switzerland.”

“FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, non-immunosuppressive treatment that can provide superior results compared to maximally dosed irbesartan, supporting replacing their RASi,” said Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics. “Together with our partner, CSL Vifor, we look forward to people living with IgAN in Switzerland gaining access to this important medicine.”

Swissmedic approval was supported by results from the pivotal phase-III PROTECT study of FILSPARI in IgAN and follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization from the European Medicines Agency in April 2024.

About CSL Vifor

CSL Vifor stands as a global partner for pharmaceuticals featuring innovative therapies focusing on iron deficiency and nephrology. The company specializes in strategic global partnerships, in-licensing, and the manufacturing and marketing of pharmaceutical products aimed at precision healthcare. Its headquarters are located in St. Gallen, Switzerland. CSL Vifor also encompasses the joint firm Vifor Fresenius Medical Care Renal Pharma, in conjunction with Fresenius Medical Care.

Parent company CSL, located in Melbourne, Australia, employs approximately 32,000 individuals and provides lifesaving therapies to those in over 100 countries. More information about CSL Vifor can be found at cslvifor.com.

About Travere Therapeutics

Travere Therapeutics is a biopharmaceutical company dedicated to helping patients and families affected by rare diseases. By partnering with the rare disease community, the company seeks to develop and deliver life-changing therapies. Its mission focuses on understanding diverse patient perspectives and creating new pathways to provide hope now and in the future. More details can be found at travere.com.

About IgA Nephropathy (IgAN)

IgAN, also known as Berger’s disease, is a uncommon progressive kidney ailment characterized by the accumulation of immunoglobulin A (IgA) in the kidneys. This buildup interferes with normal kidney filtering, resulting in symptoms like blood in the urine (hematuria), protein in the urine (proteinuria), and eventual kidney function loss. Other issues may include swelling (edema) and high blood pressure.

While IgAN is rare, it stands as the most prevalent type of primary glomerular disease globally and represents a leading cause of kidney failure. The condition is estimated to impact up to 250,000 individuals across licensed regions in Europe, Australia, and New Zealand.

About FILSPARI (sparsentan)

FILSPARI is a groundbreaking, non-immunosuppressive therapeutic compound that works as a dual endothelin and angiotensin receptor antagonist. It exhibits high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). For further details, please refer to the product overview available on the Swissmedic website.

Travere Therapeutics developed FILSPARI, which has received Orphan Drug Designation for IgAN treatment in both Europe and the U.S. The medication is currently available in the U.S. and initial European markets. CSL Vifor holds exclusive rights for FILSPARI’s marketing in Europe, Australia, and New Zealand.

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SOURCE Vifor International AG (CSL Vifor)