CSL Vifor and Travere Therapeutics, Inc., announced that Swissmedic has granted temporary marketing authorization for FILSPARI for treating adults with primary IgA nephropathy (IgAN) who exhibit urine protein excretion of at least 1.0 g/day, or a urine protein-to-creatinine ratio of at least 0.75 g/g. This decision is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial.
Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, stated that Swissmedic’s approval underscores the commitment to providing transformational medicines for patients with serious illnesses in their areas of focus. She highlighted the urgent medical need for targeted IgAN therapy and expressed eagerness to make this treatment available to patients in Switzerland promptly. Gratitude was extended to trial participants and partners at Travere for achieving this regulatory milestone in Switzerland.
Eric Dube, Ph.D., President and CEO of Travere Therapeutics, emphasized that FILSPARI directly targets kidney damage, offering a convenient once-daily oral treatment without immunosuppressive effects. This makes it a superior option compared to maximally dosed irbesartan, facilitating the replacement of current RASi treatments. He expressed anticipation of providing access to FILSPARI in Switzerland through collaboration with CSL Vifor.
Swissmedic’s approval follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization by the European Medicines Agency in April 2024, supported by the phase-III PROTECT study’s findings.
CSL Vifor, based in St. Gallen, Switzerland, is a global leader in pharmaceuticals, focusing on innovative therapies for iron deficiency and nephrology. It partners globally to develop, manufacture, and market pharmaceutical products aimed at improving patient health worldwide.
Travere Therapeutics is a biopharmaceutical company dedicated to assisting patients with rare diseases by developing and delivering life-changing therapies. The company actively collaborates with the rare disease community to meet the urgent need for treatment options.
IgA Nephropathy, also known as Berger’s disease, is a rare, progressive kidney disease where immunoglobulin A deposits impair kidney filtering mechanisms, causing symptoms like hematuria, proteinuria, edema, and high blood pressure. Despite its rarity, IgAN is the most common type of primary glomerular disease globally and a leading cause of kidney failure.
FILSPARI, developed by Travere Therapeutics, is a non-immunosuppressive dual endothelin angiotensin receptor antagonist targeting the endothelin A receptor and angiotensin II subtype 1 receptor. It has been granted Orphan Drug Designation for IgAN treatment in Europe and the U.S. CSL Vifor holds exclusive commercialization rights for FILSPARI in Europe, Australia, and New Zealand.