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Novartis Gains Canada Nod for Fabhalta in Rare Kidney Disease

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-- 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.

Price: $146.84, Change: $-1.01, Percent Change: -0.68%

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