Swissmedic Approves Filspari (sparsentan) for IgA Nephropathy
核心洞察
Swissmedic grants temporary marketing authorization for Filspari to treat IgA nephropathy (搜索) in adults with specific urine protein excretion levels.
The approval is based on Phase 3 PROTECT trial results, demonstrating statistically significant and clinically meaningful outcomes.
Filspari, a once-daily oral medication, targets kidney damage directly and offers a non-immunosuppressive alternative to RASi treatments.
CSL Vifor (搜索) and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for Filspari (sparsentan) for the treatment of adults with primary IgA nephropathy (搜索) (IgAN (搜索)) who have a urine protein excretion level ≥1.0 g/day or a urine protein-to-creatinine ratio ≥0.75 g/g.
The approval is based on data from the pivotal Phase 3 PROTECT study, which demonstrated statistically significant and clinically meaningful results. Filspari is a once-daily, oral, non-immunosuppressive treatment that directly targets damage in the kidney.
Clinical Trial Data
The Swissmedic approval was supported by results from the pivotal Phase 3 PROTECT study of FILSPARI in IgAN (搜索). The PROTECT trial demonstrated the efficacy of FILSPARI compared to irbesartan, supporting its potential to replace RASi treatments. The temporary marketing authorization reflects the urgent need for targeted therapies in IgAN.
Expert Commentary
"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. Eric Dube, Ph.D., President and Chief Executive Officer of Travere Therapeutics, added, "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."
About IgA Nephropathy
IgAN (搜索), also known as Berger's disease (搜索), is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA) in the kidneys. This buildup leads to a breakdown of the kidney's filtering mechanisms, resulting in hematuria, proteinuria, and progressive loss of kidney function. IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure, affecting an estimated 250,000 people in Europe, Australia, and New Zealand.
About Filspari
Filspari (sparsentan) is a single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (搜索) (ETAR (搜索)) and the angiotensin II subtype 1 receptor (搜索) (AT1R (搜索)). It was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgAN (搜索) in Europe and the U.S. CSL Vifor (搜索) holds exclusive commercialization rights for FILSPARI in Europe, Australia, and New Zealand.
Filspari has already received 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.