CSL Vifor and Travere Therapeutics’ Filspari (sparsentan) Gains CHMP’s Positive Opinion to Treat IgA Nephropathy
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: CSL | Image: CSL
Related News:- CSL Reports Top-line Data from the P-III (AEGIS-II) Study of CSL112 for Acute Myocardial Infarction (AMI)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
