Fabhalta strengthens renal portfolio with strong IgAN data
Research from GlobalData highlights the strength of Novartis' (NOVN: VX) position in IgA nephropathy (IgAN), following strong data for Fabhalta (iptacopan).
The therapy has demonstrated promising results in its Phase III APPLAUSE-IgAN clinical trial, showing a significant slowing of kidney function decline in adults with IgAN. This positions Fabhalta as the first and only approved complement inhibitor for this progressive autoimmune kidney disease.
The drug, a complement Factor B inhibitor, received accelerated US approval in August 2024 based on its ability to reduce proteinuria. These latest trial results, which indicate a slowed estimated glomerular filtration rate (eGFR) decline, will support a submission for traditional FDA approval in 2026. This transition from accelerated to full approval is crucial as it aims to confirm the drug's real-world kidney protection beyond just biomarker improvement.
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