> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fabhalta Approved for Rare Kidney Disease
- URL: https://www.fdaweb.com/fabhalta-approved-for-rare-kidney-disease/
- Published: 2025-03-24T12:00:00.000Z
- Updated: 2026-09-14T14:56:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158875

FDA has approved a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy (C3G) to reduce proteinuria. The rare and progressive kidney disease has historically lacked targeted treatment options, and Fabhalta is the first oral inhibitor of the alternative complement pathway, which is believed to drive C3G progression, according to the company. Previously, patients relied on supportive care and broad immunosuppression to manage symptoms.

Approval was based on data from the Phase 3 APPEAR-C3G study, which demonstrated that Fabhalta led to a significant reduction in proteinuria within 14 days of treatment, with sustained effects over 12 months, Novartis says. Patients who switched to Fabhalta during the open-label period also showed improvement.

Additionally, Fabhalta showed a favorable safety profile, it says, with the most common side effects being nasopharyngitis and viral infections. Due to the risk of serious bacterial infections, the treatment is available through a Risk Evaluation and Mitigation Strategy requiring specific vaccinations.