FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease

On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis AG’s (NYSE:NVS) oral Fabhalta (iptacopan) for adults with C3 glomerulopathy (C3G) to reduce proteinuria (protein in the urine), making it the first and only treatment approved for this condition.

C3G is a rare kidney disease characterized by damage to the glomeruli (kidney filters) due to dysregulation of the complement system, specifically the alternative pathway, leading to C3 protein accumulation.

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