Novartis’ Fabhalta Clinches Another FDA Win, This Time in IgA Nephropathy

FDA Approval:
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

Clinical Efficacy:
Fabhalta achieved a 44% reduction in proteinuria from baseline in the Phase III APPLAUSE-IgAN interim analysis, compared to a 9% reduction in the placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p<0.0001).

Mechanism of Action:
Fabhalta is a first-in-class complement inhibitor that targets the alternative complement pathway, which is thought to contribute to the pathogenesis of IgAN.

Disease Impact:
Despite current standard of care, up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis.

Ongoing Studies:
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.

Additional Therapies: Novartis is also advancing the late-stage development of two additional IgAN therapies:
atrasentan, an oral endothelin A receptor antagonist, and zigakibart, a subcutaneously administered anti-APRIL monoclonal antibody.

Patient Support:
Novartis offers a comprehensive patient support program to help eligible patients access Fabhalta, including personalized assistance for navigating insurance coverage and identifying financial assistance options.