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…
Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy
Shots:
Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN)
Trial showed that Fabhalta reduced IgAN progression measured by annualized total slope of eGFR decline over 2yrs., & demonstrated favorable safety; data to be used for 2026…

