Saturday, February 24, 2024
CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) jointly announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) who have a urine protein excretion greater than 1.0 g/day (or a urine protein-to-creatinine ratio of 0.75 g/g or higher). IgAN is a rare kidney disorder and a leading cause of kidney failure. The CHMP's positive opinion paves the way for the European Commission to make its final decision regarding Conditional Marketing Authorization (CMA) for sparsentan. If approved in Europe, sparsentan would become the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist available for the treatment of IgAN.
Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, expressed optimism, stating, "The positive CHMP opinion for sparsentan marks a significant milestone toward providing this treatment option to patients in Europe with IgAN, a rare and serious condition that can lead to kidney disease. We eagerly await the European Commission's decision and remain committed to advancing CSL's mission of offering innovative treatments for kidney disease patients."
Travere Therapeutics, emphasized the significance of the CHMP's recommendation, saying, "The positive recommendation from the CHMP represents a significant advancement in providing new treatment options for individuals living with IgAN, who are at risk of progressing to kidney failure and currently have no approved non-immunosuppressive treatment options. The PROTECT Study is the only head-to-head study in IgAN against a maximally labeled dose of irbesartan, a current standard of care. The study demonstrated that treatment with sparsentan led to a rapid and sustained reduction in proteinuria and has the potential to preserve kidney function and significantly delay the time to kidney failure compared to an active comparator, suggesting long-term benefits in IgAN. We, along with CSL Vifor, eagerly await the European Commission's decision in the second quarter of 2024."
The positive CHMP opinion is based on results from the pivotal phase-III PROTECT study of sparsentan in IgAN. CSL Vifor and Travere Therapeutics had announced the submission of a Marketing Authorization Application (MAA) for CMA to the EMA in August 2022. Sparsentan had previously been granted Orphan Medicinal Product Designation by the European Commission for the treatment of IgAN.
If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. Sparsentan is currently marketed in the U.S. and has been granted accelerated approval by the U.S. Food and Drug Administration under the brand name FILSPARI® based on its efficacy in reducing proteinuria.
Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia, and New Zealand.
Source: prnewswire.com
