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On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE:NVS) Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
In December 2023, the FDA approved Fabhalta as the first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria.
This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study, which measured a reduction in proteinuria at nine months compared to placebo.
Whether Fabhalta slows kidney function decline in patients with IgAN has not been established. The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase 3 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. Approximately 25 people per million worldwide are newly diagnosed with IgAN each year.
The ongoing Phase 3 APPLAUSE-IgAN study is evaluating the efficacy and safety of twice-daily oral Fabhalta (200 mg) versus placebo in adult IgAN patients on a stable dose of maximally-tolerated renin-angiotensin system (RAS) inhibitor therapy with or without a stable dose of SGLT2i. The primary endpoint for the interim analysis was the percent reduction of proteinuria, a marker of kidney damage, measured by comparing UPCR at nine months to baseline.
Fabhalta achieved a 44% reduction in proteinuria at nine months relative to baseline, compared with a 9% reduction in the placebo arm, demonstrating a clinically meaningful and statistically significant 38% reduction vs. placebo (p<0.0001).
Fabhalta demonstrated a favorable safety profile.
Novartis is advancing the late-stage development of two additional IgAN therapies: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in Q2 2024, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in Phase 3 development.
Price Action: NVS stock is down 0.34% at $110.79 at the last check on Thursday.
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