Novartis has announced positive 12-month data from the Phase III APPEAR-C3G study, revealing that Fabhalta (iptacopan) demonstrated clinically significant and sustained benefits in patients with C3 glomerulopathy (C3G). The data, presented at the American Society of Nephrology (ASN) Kidney Week 2024, highlight the potential of Fabhalta as a targeted treatment for this rare kidney disease.
Sustained Proteinuria Reduction
The study confirmed that treatment with Fabhalta resulted in a significant reduction in proteinuria, a key indicator of kidney damage in C3G patients. This reduction was observed as early as 14 days after treatment initiation and was maintained throughout the 12-month study period. Furthermore, participants who switched to Fabhalta during the open-label phase of the study also experienced a notable decrease in proteinuria.
Improvement in eGFR Slope
An exploratory analysis of the data revealed an improvement in the estimated glomerular filtration rate (eGFR) slope following the start of Fabhalta treatment. This suggests that Fabhalta may help to slow the progression of kidney damage in C3G patients, compared to their historical rate of decline.
Favorable Safety Profile
Fabhalta demonstrated a favorable safety profile throughout the study, with no new safety signals identified. This is an important consideration for patients with C3G, who often require long-term treatment to manage their condition.
These findings suggest that Fabhalta could represent a significant advancement in the treatment of C3G, offering patients a targeted therapy with the potential to improve kidney function and slow disease progression.
