CSL Vifor and Travere Therapeutics Receive EU Approval for FILSPARI® in the Treatment of IgA Nephropathy
Tuesday, April 29, 2025
CSL Vifor and Travere Therapeutics have received full marketing authorisation from the European Commission for FILSPARI® to treat adults with primary IgA nephropathy (IgAN).
Nephropathy is a general term used to describe damage or disease affecting the kidneys. It can result from various causes, including diabetes, high blood pressure, or autoimmune conditions. One specific form, IgA nephropathy (IgAN), involves the build-up of the IgA antibody in the kidneys, leading to inflammation and impaired kidney function. Over time, this can cause a gradual decline in kidney performance and may progress to chronic kidney disease if not effectively managed.
This decision converts the previous conditional marketing approval into a standard authorisation across all European Union member states, as well as Iceland, Liechtenstein and Norway. The approval covers patients with urine protein excretion of 1.0 g/day or higher, or a urine protein-to-creatinine ratio of at least 0.75 g/g.
The standard authorisation was granted without any changes to the previously approved indication. This follows the February 2025 recommendation from the Committee for Medicinal Products for Human Use (CHMP) to transition from a conditional to a standard approval.
The decision is based on a robust clinical evidence package, including data from the pivotal Phase III PROTECT study. Results from this study showed that FILSPARI significantly slowed the decline of kidney function over a two-year period when compared to irbesartan.
FILSPARI remains the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for the treatment of IgAN. It offers a non-immunosuppressive therapy option and is already available in Germany, Austria and Switzerland under the previous conditional approval granted in April 2024.
The companies aim to continue working with healthcare providers, regulatory authorities, and patient organisations to expand access to this treatment and improve outcomes for those affected by IgA nephropathy across Europe.
Source: : csl.com
