Travere Therapeutics, Inc., (TVTX) and CSL Vifor Wednesday said the European Commission has granted conditional marketing authorization for Filspari for the treatment of adults with primary IgA nephropathy (IgAN), a rare kidney disorder.
The European Commission's decision follows positive opinion of the Committee for Medicinal Products for Human Use (CHMP) in February this year, based on results from the Phase 3 PROTECT Study of Filspari in IgAN.
CSL Vifor, which possesses exclusive commercialization rights for Filspari in Europe, Australia and New Zealand, expects to launch the drug in the second half of 2024.
In February last year, Filspari was granted accelerated approval by the US Food and Drug Administration to reduce proteinuria in adults with IgAN.
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