Shots:
- The CHMP has granted positive opinion to CSL (exclusive commercialization rights holder in the EU, Australia & New Zealand) & Travere’s sparsentan for its conditional approval to treat primary IgAN with a urine protein excretion >1.0 g/day. EC’s decision is anticipated in Q2’24
- The opinion was supported by the P-III (PROTECT) trial investigating the safety & efficacy of sparsentan (400mg) vs irbesartan (300mg) in IgAN patients (n=404, 18yrs. of age & above) with persistent proteinuria after receiving MTD and at least -50% of maximum labelled dose of ACE/ARB therapy
- The results depicted fast & sustained proteinuria reduction, ability of sparsentan to preserve kidney function & delay time to kidney failure
Ref:Travere Therapeutics | Image: Travere Therapeutics & CSL| Press Release
Related News:- Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)
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