CSL Vifor and Travere Therapeutics Receive Full EU Approval for FILSPARI® in IgA Nephropathy
Tuesday, April 29, 2025
CSL Vifor and Travere Therapeutics, Inc. have announced that the European Commission has granted full marketing authorisation for FILSPARI® (sparsentan) to treat adults with primary IgA nephropathy (IgAN) who have a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of at least 0.75 g/g. This standard authorisation replaces the earlier conditional approval and is valid across all European Union member states, as well as Iceland, Liechtenstein, and Norway.
The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in February 2025. It is supported by a robust clinical evidence base, including results from the phase-III PROTECT study, which showed that FILSPARI significantly slowed the decline in kidney function over two years compared to irbesartan.
FILSPARI is currently the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) authorised in Europe for the treatment of IgAN. It is a non-immunosuppressive option and is already available in Germany, Austria, and Switzerland under the previous conditional approval granted in April 2024.
The transition to standard approval reflects confidence in the therapy’s safety and efficacy profile and marks an important step forward in improving access and outcomes for people living with IgA nephropathy across Europe.
Source: prnewswire.com
