Travere Therapeutics (TVTX) and CSL Vifor said Tuesday that the European Commission has converted the conditional marketing approval of Filspari into a standard marketing authorization for the treatment of adults with primary IgA nephropathy.
IgAN, also known as Berger's disease, is a rare but progressive kidney disease characterized by the buildup of immunoglobulin A in the kidneys, which impairs the normal filtering mechanisms.
The decision follows the recommendation by the Committee for Medicinal Products for Human Use in February to convert the conditional approval to standard marketing authorization. The CHMP's recommendation was supported by clinical data, including positive confirmatory results from the pivotal Phase 3 Protect study, which demonstrated that Filspari significantly slowed kidney function decline over two years compared to irbesartan.
Filspari is the only dual endothelin angiotensin receptor antagonist and non-immunosuppressive therapy for the treatment of IgAN approved in Europe. It was developed by Travere Therapeutics, while CSL Vifor holds the exclusive commercialization rights for Filspari in Europe, Australia, and New Zealand.
Shares of Travere Therapeutics were up 1.5% in recent trading.
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