EU grants conditional marketing authorization for Travere's FILSPARI in IgA nephropathy

Travere Therapeutics, Inc.

European Commission approved FILSPARI (sparsentan) for adults with primary IgAN with urine protein excretion ≥1.0 g/day or UPCR ≥0.75 g/g.
Approval covers all EU member states plus Iceland, Liechtenstein, Norway; follows CHMP positive opinion in February 2024.
Decision based on pivotal Phase 3 PROTECT Study results; FILSPARI already has accelerated approval in the US.
CSL Vifor holds exclusive commercialization rights in Europe, Australia, New Zealand; expects launch in first European markets in H2 2024.

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