Swissmedic Approves FILSPARI® (sparsentan) for IgA Nephropathy Treatment

Travere Therapeutics, Inc., alongside CSL Vifor, has announced that Swissmedic has granted temporary marketing authorization for FILSPARI to treat adults with primary IgA nephropathy (IgAN) showing urine protein excretion of at least 1.0 g/day or a urine protein-to-creatinine ratio of 0.75 g/g or higher.

FILSPARI is recognized for its capability to target kidney damage directly and offers patients a convenient, once-daily, oral treatment that is non-immunosuppressive. This treatment promises superior results compared to the maximum dosage of irbesartan, potentially replacing RAS inhibitors. Eric Dube, Ph.D., Travere Therapeutics' President and CEO, expressed his optimism about the Swiss patients gaining access to this significant medicine, in partnership with CSL Vifor.

Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, highlighted Swissmedic's approval as a testament to their commitment to delivering transformational medicines for severe diseases. Given the high unmet medical need for targeted IgAN treatment, CSL looks forward to providing the innovative treatment to the Swiss IgAN community promptly. Brisset extended gratitude to clinical trial participants and partners at Travere for their dedication to achieving this regulatory milestone in Switzerland.

The Swissmedic approval relies on the pivotal results from the Phase 3 PROTECT Study of FILSPARI in IgAN patients. This follows the full marketing approval from the U.S. Food and Drug Administration in September 2024 and the conditional marketing authorization by the European Medicines Agency in April 2024. Travere Therapeutics had granted CSL Vifor exclusive rights for FILSPARI commercialization in Europe, Australia, and New Zealand in 2021.

Travere Therapeutics is deeply invested in helping patients, families, and caregivers manage life with rare diseases. Their global team collaborates with the rare disease community to develop and deliver life-changing therapies. They strive to understand the diverse perspectives within this community and courageously seek new paths to make significant impacts on patients' lives.

CSL Vifor specializes in pharmaceuticals and innovative therapies in iron deficiency and nephrology. They focus on strategic global partnerships, in-licensing, and developing, manufacturing, and marketing pharmaceutical products for precision healthcare. Their goal is to improve patients' lives by delivering leading therapies. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes Vifor Fresenius Medical Care Renal Pharma, a joint venture with Fresenius Medical Care. The parent company, CSL, is based in Melbourne, Australia, and serves patients in over 100 countries with a workforce of 32,000 employees.

IgA nephropathy, also known as Berger’s disease, is a rare progressive kidney disorder marked by immunoglobulin A (IgA) deposits in the kidneys, disrupting normal filtering mechanisms. This leads to blood in the urine, proteinuria, and progressive kidney function loss. Symptoms might also include swelling and high blood pressure. Despite its rarity, IgAN is the most common primary glomerular disease worldwide and a significant cause of kidney failure, impacting around 250,000 people in licensed territories including Europe, Australia, and New Zealand.

FILSPARI (sparsentan) is authorized in the U.S. to slow kidney function decline in adults with primary IgAN at risk of disease progression. However, it carries crucial safety information due to risks of hepatotoxicity and embryo-fetal toxicity, necessitating its availability only through a restricted program called the FILSPARI REMS. This program requires enrollment of prescribers, patients, and pharmacies and adherence to specific protocols to ensure safe administration.

The approval of FILSPARI reflects a significant advancement in the treatment of primary IgAN, offering a new hope for patients and healthcare providers focused on managing this complex and challenging disease.