Travere and CSL Vifor receive CHMP positive opinion for sparsentan in IgAN in EU

Travere Therapeutics, Inc.

EMA CHMP recommended conditional marketing authorization for sparsentan for primary IgAN with proteinuria >1.0 g/day.
Positive opinion based on Phase 3 PROTECT Study results; EC final decision pending.
If approved, sparsentan would get CMA in all EU member states plus Iceland, Liechtenstein, Norway.
Already marketed in US as FILSPARI under accelerated approval for proteinuria reduction.

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