Travere Therapeutics and CSL Vifor announced that the European Commission has granted standard approval to sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion of 1.0 g/d or higher or a urine protein-to-creatinine ratio of 0.75 g/g or higher.
The drug, which is marketed under the brand name Filspari, was previously granted conditional marketing approval. The conversion to standard marketing authorization applies to all members of the European Union, Iceland, Liechtenstein, and Norway.
The decision was supported by data from the phase 3 PROTECT study, which compared sparsentan, a dual endothelin angiotensin receptor antagonist, with the angiotensin receptor blocker irbesartan. After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8% versus 15.1% with irbesartan. Two-year confirmatory results demonstrated that sparsentan significantly slowed kidney function decline when compared with irbesartan.
Conditional approval of sparsentan for IgAN in the United Kingdom was converted to standard approval effective April 15, 2025. The drug received full approval for the treatment of IgAN in the United States in September 2024.
Source: Travere Therapeutics. Accessed April 30, 2025. https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-and-CSL-Vifor-Announce-Standard-EU-Approval-of-FILSPARI-sparsentan-for-IgA-Nephropathy/default.aspx
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