Shots:
- The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression
- Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline of −3 vs −5.7mL/min/1.73 m²/year, demonstrating kidney function preservation
- Fabhalta consistently outperformed PBO across key kidney outcomes, with clinically meaningful reductions in urinary protein observed as early as 2wks. & sustained throughout the treatment period
Ref: Globenewswire | Image: Novartis | Press Release
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