Biopharmaceutical company Travere Therapeutics Inc (NASDAQ:TVTX) and iron deficiency and nephrology specialist CSL Vifor, part of Australian biotechnology company CSL Limited (ASX:CSL), announced on Tuesday that they have received standard marketing authorisation from the European Commission for FILSPARI (sparsentan) in the treatment of primary IgA nephropathy (IgAN) in adults with significant proteinuria.

This decision converts the conditional marketing authorisation granted in April 2024 into full approval, extending to all European Union member states, as well as Iceland, Liechtenstein and Norway.

The approval is supported by the full data set from the phase-III PROTECT study, which showed that FILSPARI significantly slowed the decline in kidney function over a two-year period compared to irbesartan. The Committee for Medicinal Products for Human Use issued a positive recommendation in February 2025, paving the way for the Commission's decision.

FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN and offers a non-immunosuppressive treatment option. It is already commercially available in Germany, Austria and Switzerland.