Novartis wins FDA traditional approval for Fabhalta in primary IgA nephropathy

• Novartis won FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy.
• Phase III APPLAUSE-IgAN data showed a 48% slower eGFR decline versus placebo over two years.
• Annualized eGFR change was -3.0 mL/min/1.73 m²/year versus -5.7 for placebo.
• Fabhalta previously held accelerated approval in August 2024 for reducing proteinuria in primary IgA nephropathy.
• Drug carries serious infection risk; distributed via REMS with required vaccinations.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novartis AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607161902OMX_____CNEWS_EN_GNW1001213145_en) on July 16, 2026, and is solely responsible for the information contained therein.