Novartis A/S (NYSE:NVS) on Thursday shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).
NVS is in positive territory. See the complete data here
IgA nephropathy, also known as Berger's disease, is an autoimmune kidney disease in which clumps of antibodies, specifically immunoglobulin A (IgA), accumulate in the kidney's filters, leading to inflammation and damage.
Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years.
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eGFR is a blood test that estimates how well the kidneys are filtering waste from the blood.
In APPLAUSE-IgAN, Fabhalta was well tolerated with a favorable safety profile in line with previously reported data. Full data from the APPLAUSE-IgAN final analysis will be presented at future medical meetings.
Novartis will use these data to support Fabhalta submissions in 2026. Alongside Fabhalta, Novartis continues to advance its multi-asset IgAN portfolio, including Vanrafia (atrasentan) and investigational compound zigakibart.
Fabhalta Background
Fabhalta (iptacopan) is an oral Factor B inhibitor of the alternative complement pathway.
Discovered at Novartis, Fabhalta received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval in December 2023 and May 2024, respectively, for adults with paroxysmal nocturnal hemoglobinuria (PNH).
Fabhalta also received accelerated approval in the U.S. in August 2024 and in China in September 2025 to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression.
In 2025, Fabhalta received FDA and EC approval and approvals in China and Japan for adults with C3 glomerulopathy (C3G), making it the first treatment approved for this condition.
In August, the U.S. Food and Drug Administration (FDA) approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.'s (NASDAQ:TVTX) Filspari (sparsentan) for IgAN.
The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with Filspari.
It removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.
In August, Vor Bio Inc. (NASDAQ:VOR) announced that its collaborator, RemeGen Co., Ltd., achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgAN.
In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo (p<0.0001).
Price Action: Novartis shares were up 0.68% at $130.86 at the time of publication on Thursday. The stock is approaching its 52-week high of $133.55, according to Benzinga Pro data.
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