European Commission conditionally approves Filspari (sparsentan) for the treatment of IgA Nephropathy

The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

"This is a significant step forward for patients in Europe living with IgAN, a rare and serious condition, and a leading cause of end stage renal disease," said Prof. Dr. med. Jürgen Floege, Senior Professor, Div. Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial. "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN. Adult patients with IgAN who are at high risk of progressing to kidney failure will now have access to a new therapy that significantly reduces proteinuria and slows the progression of kidney disease."

The EU decision is based on results from the pivotal phase-III PROTECT study of Filspari in IgAN. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving Filspari achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with Filspari achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation.