Thursday, April 25, 2024
CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) jointly announced today that FILSPARI (sparsentan) has been granted conditional marketing authorization (CMA) by the European Commission. This authorization allows the use of FILSPARI for treating adults with primary IgA nephropathy (IgAN) who exhibit a urine protein excretion of ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g) across all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway.
Prof. Dr. med. Jürgen Floege, Senior Professor at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial, hailed this approval as a significant milestone for IgAN patients in Europe. He emphasized the rarity and severity of IgAN and stressed the urgent need for effective treatments. He noted that FILSPARI's approval is based on data from the only head-to-head phase-III clinical trial in IgAN, demonstrating its ability to notably reduce proteinuria and decelerate kidney disease progression.
Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL, expressed their dedication to addressing unmet needs in diseases like IgAN and expressed readiness to collaborate with partners and EU member states to ensure access to this therapy for patients.
Eric Dube, Ph.D., President and CEO of Travere Therapeutics, highlighted FILSPARI's significance as the first non-immunosuppressive therapy approved for IgAN. He noted its potential to become a foundational treatment for the disease, replacing current therapies.
The European Commission's decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in February 2024, based on the pivotal phase-III PROTECT study of FILSPARI in IgAN. This study demonstrated significant reductions in proteinuria and clinically meaningful preservation of kidney function compared to current treatments.
IgA Nephropathy (IgAN), also known as Berger's disease, is a rare kidney disease characterized by the accumulation of immunoglobulin A (IgA) in the kidneys, leading to impaired kidney function and other symptoms such as blood and protein in the urine, swelling, and high blood pressure.
The PROTECT study is one of the largest interventional studies in IgAN to date and the only head-to-head trial in this disease. It showed that FILSPARI, a novel dual endothelin angiotensin receptor antagonist, significantly outperformed current therapies in reducing proteinuria and preserving kidney function.
FILSPARI, developed by Travere Therapeutics, has been granted Orphan Drug Designation in Europe and the U.S. It was previously approved in the U.S. and has now received conditional marketing authorization in Europe. CSL Vifor holds exclusive commercialization rights for FILSPARI in Europe, Australia, and New Zealand.
Source: prnewswire.com
