Travere Therapeutics, Inc. and CSL Vifor announced that Swissmedic has granted temporary marketing authorization for FILSPARI 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).
“FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, non-immunosuppressive treatment that can provide superior results compared to maximally dosed irbesartan, supporting replacing their RASi,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Together with our partner, CSL Vifor, we look forward to people living with IgAN in Switzerland gaining access to this important medicine.”
“Swissmedic approval further demonstrates our promise to deliver transformational medicines for patients with serious diseases in our areas of focus,” said Emmanuelle Lecomte Brisset, senior vice president and head of global regulatory affairs at CSL. “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, as well as our partners at Travere, for their dedication to deliver this important regulatory approval in Switzerland.”
Swissmedic approval was supported by results from the pivotal Phase 3 PROTECT Study of FILSPARI in IgAN and follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization by the European Medicines Agency in April 2024.
In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!