-- Novartis (NVS) said Health Canada has approved Fabhalta for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
C3G is a rare, long-term kidney disease caused by an overactive immune pathway. This leads to a buildup of protein in the kidneys, causing inflammation, damage and, over time, loss of kidney function.
The approval was backed by Phase III data showing a statistically significant reduction in proteinuria at six months, with sustained benefits through one year.
Fabhalta (iptacopan) is an oral drug that blocks a key part of the immune system (Factor B), helping reduce the harmful activity that drives C3G and protects the kidneys.
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