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Travere Therapeutics Says Berger's Disease Treatment Granted EU Conditional Marketing Authorization
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Travere Therapeutics Says Berger's Disease Treatment Granted EU Conditional Marketing Authorization
Apr 24, 2024 1:48 AM

04:27 AM EDT, 04/24/2024 (MT Newswires) -- Travere Therapeutics ( TVTX ) and CSL Vifor said Wednesday the European Commission granted conditional marketing authorization for Filspari as a treatment for adults with primary Immunoglobulin A Nephropathy, or Berger's disease.

CSL Vifor expects to launch sales of the drug in Europe beginning in H2. The authorization for the treatment, also known as sparsentan, includes all European Union member states as well as Iceland, Liechtenstein and Norway.

The authorization followed a phase 3 trial that met its primary endpoint and a positive assessment of the drug by the Committee for Medicinal Products for Human Use in February, the companies said.

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