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Novartis Fabhalta wins FDA approval to slow kidney decline in primary IgA nephropathy

17. Jul 2026

(AWP Alliance News) - Novartis won FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy at risk of progression. The drug cut eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study.

Fabhalta had received accelerated clearance in August 2024 for reducing proteinuria in the same condition.

https://www.publicnow.com/view/2173B8F7778C7B3FBEE11B3E3976300A918575EC…

Disclaimer: This news brief was created using generative artificial intelligence. Novartis AG published the original content used to generate this news brief on July 17, 2026, and is solely responsible for the information contained therein.

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