Novartis Receives FDA Accelerated Approval For Fabhalta As First Complement Inhibitor For IgAN

(RTTNews) - Novartis (NVS) announced that the U.S. Food and Drug Administration has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy or IgAN at risk of rapid disease progression.

The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase III APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline over 24 months. The eGFR data are expected at study completion in 2025 and are intended to support traditional FDA approval.

IgAN is a progressive, rare disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria. About 25 people per million worldwide are newly diagnosed with IgAN each year. Each person's disease journey is unique as IgAN progresses differently and treatment responses vary as well.

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