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Novartis’ Complement Inhibitor Fabhalta Approved for IgAN

Marks the first FDA approval from Novartis’ renal pipeline, which also includes atrasentan and zigakibart.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Novartis for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.   IgAN is a rare but serious kidney disorder affecting millions worldwide. Despite being a progressive condition, treatment options have been limited. Fabhalta’s approval marks a potential breakthrough in addr...

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