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# Accelerated Approval for Novartis’ Fabhalta
- URL: https://www.fdaweb.com/accelerated-approval-for-novartis-fabhalta/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157537

FDA has given accelerated approval to Novartis’ Fabhalta (iptacopan) for reducing proteinuria in primary IgA nephropathy. A company [statement](https://www.prnewswire.com/news-releases/novartis-receives-fda-accelerated-approval-for-fabhalta-iptacopan-the-first-and-only-complement-inhibitor-for-the-reduction-of-proteinuria-in-primary-iga-nephropathy-igan-302217305.html?ref=fdaweb.com) says Fabhalta is a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.

The accelerated approval was based on the pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study measuring reduction in proteinuria at nine months compared to placebo, Novartis says.