Novartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® (iptacopan) at the late-breaking clinical trials session of the European Renal Association (ERA) Congress1. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% (p=0.0014) reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 6 months when compared to placebo on top of supportive care1. In many kidney diseases, proteinuria reduction is an increasingly recognized surrogate marker correlating with delaying progression to kidney failure.
Fabhalta is an oral Factor B inhibitor of the alternative complement pathway being investigated in adult patients with C3 glomerulopathy (C3G)1-3. Regulatory submissions, including to the FDA and EMA, for the adult C3G indication are planned for the second half of 2024.
