SAN DIEGO - The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of sparsentan, a treatment for IgA nephropathy (IgAN), in Europe. This recommendation by the European Medicines Agency's (EMA) expert panel is a critical step towards conditional marketing authorization (CMA) for adults with primary IgAN who exhibit significant proteinuria. Travere Therapeutics, Inc. (NASDAQ: TVTX), in collaboration with CSL (OTC:CSLLY) Vifor, announced the positive opinion, which is based on the Phase 3 PROTECT Study results.
The European Commission is expected to make a final decision on sparsentan's CMA in the second quarter of 2024. If approved, sparsentan would be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist available in Europe for IgAN treatment. This rare kidney disease, also known as Berger’s disease, can lead to kidney failure and currently lacks approved non-immunosuppressive treatment options.
The PROTECT Study, which is the only head-to-head study against irbesartan, a current standard of care, showed that sparsentan treatment resulted in a rapid and sustained reduction in proteinuria. This could potentially preserve kidney function and significantly delay the progression to kidney failure in IgAN patients. Eric Dube, Ph.D., president and CEO of Travere Therapeutics, emphasized the long-term benefits of sparsentan demonstrated in the study.
Travere Therapeutics and CSL Vifor submitted a Marketing Authorization Application for sparsentan to the EMA in August 2022, following the drug's Orphan Medicinal Product Designation by the European Commission. Sparsentan is already marketed in the U.S. under the brand name FILSPARI®, having received accelerated approval based on proteinuria reduction. The companies have an agreement granting CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia, and New Zealand.
This development is seen as a significant step forward for the approximately 250,000 people affected by IgAN within the licensed territories. Both companies expressed their anticipation for the European Commission's upcoming decision and their commitment to delivering innovative treatments to patients with kidney diseases.
The information in this article is based on a press release statement from Travere Therapeutics, Inc.
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