Shots:

• The US FDA has granted full approval to Filspari (400mg) for treating IgAN, based on the P-III (PROTECT) trial assessing the drug vs irbesartan (300mg) in subjects (n=404) aged ≥18yrs. It received accelerated approval in Feb 2023
• Final 2yrs. ITT analysis showed reduction in the rate of kidney function decline at wk.110. The mean eGFR slope was -3.0 mL/min/1.73 m2/year vs -4.2 mL/min/1.73 m2/year, with a significant treatment effect of 1.2 mL/min/1.73 m²/year; additional benefits showed improved eGFR over time, with a 3.8 mL/min/1.73 m² greater mean change
• Safety was well-tolerated and consistent in all the studies. An sNDA to the US FDA is planned for a potential modification to the liver-monitoring REMS

Ref: Travere Therapeutics  | Image: Travere Therapeutics 

Related News:- CSL Vifor and Travere Therapeutics’ FILSPARI (sparsentan) Received European Commission Approval Against IgA Nephropathy

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com