On Friday, the U.S. Food and Drug Administration (FDA) granted traditional approval for Novartis AG’s (NYSE:NVS) oral medication, Fabhalta (iptacopan).
The treatment is authorized to slow the decline of kidney function in adult patients suffering from primary immunoglobulin A nephropathy (IgAN) who face a high risk of disease progression.
Because IgAN can progress to kidney failure requiring dialysis or a transplant, slowing kidney function decline with Fabhalta could help delay the need for those interventions in at-risk patients.
Fabhalta, recognized as a first-in-class complement inhibitor, secured this traditional approval following a priority review.
It previously obtained accelerated FDA approval in August 2024 for reducing proteinuria in primary IgAN patients.
Addressing IgA Nephropathy Progression
IgAN ranks among the most prevalent autoimmune kidney disorders, with roughly 25 individuals per million receiving a diagnosis globally each year.
For patients experiencing persistent proteinuria, up to 50% may progress to kidney failure within a decade or two.
This severe outcome often necessitates dialysis or organ transplantation.
APPLAUSE-IgAN Study Data And Safety
The FDA based its decision on results from the Phase 3 APPLAUSE-IgAN clinical trial.
The study highlighted a clinically meaningful enhancement in the estimated glomerular filtration rate (eGFR) across two years.
Specifically, patients treated with Fabhalta demonstrated an annualized mean eGFR decline of just -3.0 mL/min/1.73 m2/yr, compared to a steeper decline of -5.7 mL/min/1.73 m2/yr in the placebo group.
The drug consistently outperformed the placebo across critical renal metrics.
While Fabhalta maintained a favorable safety record consistent with prior data.
Due to the potential risk of severe infections from encapsulated bacteria, the drug is dispensed exclusively through a Risk Evaluation and Mitigation Strategy program, which mandates proper vaccinations before initiating therapy.
Expanding Novartis Kidney Disease Portfolio
Designed to selectively target the alternative complement pathway by inhibiting Factor B, the oral medication aims to mitigate ongoing kidney injury.
To support the patient community, Novartis offers robust financial assistance, enabling nearly all eligible U.S. patients to access Fabhalta for $10 or less monthly.
The company continues to broaden its IgAN pipeline, which also features Vanrafia and the experimental drug zigakibart.
NVS Stock Price Activity: Novartis shares were up 1.01% at $154.28 at the time of publication on Friday, according to Benzinga Pro data.
Photo: Shutterstock
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