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Novartis' Fabhalta Shows Promise in Kidney Disease Treatment

10/18/2025

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Summary

Story summary

Novartis announced positive results from Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan) in IgA nephropathy.
The accelerated approval for reducing proteinuria in adults with IgA nephropathy was granted in 2024, with traditional approval planned for 2026.
Fabhalta demonstrated significant slowing of eGFR decline, a key kidney function marker.
Novartis aims to address unmet kidney-disease needs with proactive treatments rather than reactive, advanced-care approaches.

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Story summary

Novartis announced positive results from Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan) in IgA nephropathy.
The accelerated approval for reducing proteinuria in adults with IgA nephropathy was granted in 2024, with traditional approval planned for 2026.
Fabhalta demonstrated significant slowing of eGFR decline, a key kidney function marker.
Novartis aims to address unmet kidney-disease needs with proactive treatments rather than reactive, advanced-care approaches.