Novartis presents latest Phase III Fabhalta data in C3 glomerulopathy

Novartis presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta, or iptacopan, at the late-breaking clinical trials session of the European Renal Association Congress. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% reduction in proteinuria at 6 months when compared to placebo on top of supportive care. In many kidney diseases, proteinuria reduction is an increasingly recognized surrogate marker correlating with delaying progression to kidney failure. Additional data on the secondary endpoint of estimated glomerular filtration rate, a measure of kidney function, showed a numerical improvement of +2.2 mL/min/1.73 m2 over 6 months with Fabhalta compared to placebo. The study also showed Fabhalta has a favorable safety profile with no new safety signals. The APPEAR-C3G study continues with an additional 6-month, open-label period following the 6-month double-blind period, in which all patients receive Fabhalta, including those previously receiving placebo2,3. These data will be presented at an upcoming medical meeting when available. At ERA, Novartis is also presenting new data across its rare disease portfolio, including results for investigational atrasentan in IgA nephropathy from the 36-week interim analysis of the Phase III ALIGN study, additional data for Fabhalta in IgAN from the 9-month interim analysis of the Phase III APPLAUSE-IgAN study, long-term 33-month efficacy and safety data for Fabhalta in C3G from the Phase II extension study, 1-year Phase I/II data for investigational zigakibart in IgAN, and data from real-world studies in C3G and atypical hemolytic uremic syndrome.