Sparsentan Approved in Europe for Treatment of IgAN

The European Commission granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA applies to all member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

CMA was granted based on results from the phase 3 PROTECT trial. After 36 weeks of treatment, patients who received FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8%, versus 15.1% for patients receiving irbesartan. The 2-year confirmatory results from PROTECT showed treatment with FILSPARI achieved statistical significance on the estimated glomerular filtration rate chronic slope end point versus irbesartan and showed clinically meaningful preservation of kidney function.

FILSPARI is a single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor and the angiotensin II subtype 1 receptor. It was developed by Travere Therapeutics and has been granted orphan drug designation for the treatment of IgAN in Europe and the United States. It received accelerated approval by the US Food and Drug Administration in February 2023.

CSL Vifor has exclusive commercialization rights for FILSPARI in Europe, Australia, and New Zealand, and it hopes to launch the drug in the first European markets in the second half of 2024.

IgAN is the most common type of primary glomerular disease globally and is a primary cause of kidney failure.