CSL Vifor and Travere Secure Swissmedic Approval, Major Step Forward in IgA Nephropathy Treatment

CSL Vifor and Travere Therapeutics, Inc. have announced that Swissmedic has granted temporary marketing authorisation for FILSPARI to treat adults with primary IgA nephropathy (IgAN) who have urine protein excretion of ≥1.0 g/day (or a urine protein-to-creatinine ratio of ≥0.75 g/g). 

Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL said in a statement, "Swissmedic approval further demonstrates our promise to deliver transformational medicines for patients with serious diseases in our areas of focus. There is a high unmet medical need for a targeted therapy to treat IgAN, and we look forward to providing access to this innovative treatment option for the Swiss IgAN community as fast as possible. Thank you to all of the patients who participated in the clinical trials and our partners at Travere for their dedication to delivering this important regulatory approval in Switzerland."

The approval is based on results from the pivotal phase-III PROTECT study. It follows full U.S. FDA approval in September 2024 and conditional approval for marketing by the European Medicines Agency in April 2024.

"FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, non-immunosuppressive treatment that can provide superior results to maximally dosed irbesartan, supporting replacing their RASi. Together with our partner, CSL Vifor, we look forward to people living with IgAN in Switzerland gaining access to this important medicine," mentioned Eric Dube, PhD, President and Chief Executive Officer of Travere Therapeutics.