CSL Vifor and Travere Therapeutics Inc. (TVTX) said that the European Medicines Agency's or EMA CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy with a urine protein excretion greater than 1.0 g/day.
IgA nephropathy or IgAN is a rare kidney disorder and a leading cause of kidney failure.
The positive Committee for Medicinal Products for Human Use or CHMP opinion is based on results from the pivotal phase-III PROTECT study of sparsentan in IgAN.
The CHMP opinion provides the basis for the European Commission's final decision regarding the conditional marketing authorization for sparsentan. The European Commission decision is expected in the second quarter of 2024.
If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.
In August 2022, CSL Vifor and Travere Therapeutics announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA. The European Commission previously granted Orphan Medicinal Product Designation to sparsentan for the treatment of IgAN.
If approved, sparsentan would receive a 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 granted accelerated approval by the U.S. Food and Drug Administration under the brand name FILSPARI based on reduction in proteinuria.
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