The approval was based on the results from the Phase 3 PROTECT study which reached its primary endpoint during the pre-specified interim analysis
EC clears Filspari for the treatment of IgA nephropathy. (Credit: CSL)
Travere Therapeutics and CSL Vifor have received conditional marketing authorisation (CMA) from the European Commission (EC) for Filspari (sparsentan) to treat immunoglobulin A (IgA) nephropathy.
Filspari is an endothelin and angiotensin II receptor antagonist. It lowers proteinuria in adults with primary IgA nephropathy (IgAN).
The EC has conditionally approved Filspari to treat adult patients with primary IgAN with a urine protein excretion ≥1.0g/day in all member states of the European Union.
The approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) in February and was based on the results from the Phase 3 PROTECT Study.
The randomised, multicentre, double-blind clinical trial assessed the safety and efficacy of 400mg of sparsentan against 300mg of irbesartan in 404 patients.
The PROTECT Study reached its primary endpoint during the pre-specified interim analysis, demonstrating statistical significance.
Over 36 weeks, patients administered Filspari experienced a mean reduction in proteinuria from baseline by 49.8%, compared to irbesartan-treated patients, who achieved a mean reduction of 15.1%.
The two-year confirmatory results from the study revealed that Filspari treatment significantly preserved kidney function, as indicated by the eGFR chronic slope endpoint compared to irbesartan, demonstrating clinically meaningful outcomes.
Travere Therapeutics president and CEO Eric Dube said: “With this approval and the commercial strength and expertise of our partner, CSL Vifor, we look forward to people living with IgAN in Europe gaining access to this important medicine.”
Travere Therapeutics spearheaded the development of Filspari, earning orphan drug designation for treating IgAN in both Europe and the US.
Currently available in the US, Filspari received accelerated approval from the US Food and Drug Administration in February 2023.
CSL Vifor holds exclusive commercialisation rights for sparsentan in Europe, Australia, and New Zealand.
The company anticipates introducing Filspari into the initial European markets during the latter half of 2024.
CSL Vifor senior vice president and global regulatory affairs head Emmanuelle Brisset said: “The approval by the European Commission is an important milestone for the IgAN community in Europe and underscores our promise to develop and deliver innovative medicines in our areas of focus where there is unmet need.”