Novartis Wins FDA Traditional Approval For Fabhalta To Slow Kidney Function Decline In IgA Nephropathy

Novartis has announced that the U.S. Food and Drug Administration (FDA) has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Fabhalta, the first complement inhibitor approved for this condition, previously received accelerated approval in August 2024 to reduce proteinuria in patients with primary IgAN. The latest approval, granted under the FDA's priority review process, is based on clinical evidence showing the therapy's ability to preserve kidney function over the long term.

IgA nephropathy is a chronic autoimmune kidney disease in which the immune system damages the kidneys, often leading to progressive loss of kidney function. Each year, around 25 people per million worldwide are newly diagnosed with the condition. Up to half of patients with persistent proteinuria may progress to kidney failure within 10 to 20 years of diagnosis, frequently requiring dialysis or a kidney transplant. Because of this, slowing the decline in kidney function has become one of the most important treatment goals for patients and healthcare providers.

The approval was supported by results from the Phase III APPLAUSE-IgAN clinical trial, which demonstrated that Fabhalta significantly slowed kidney function decline compared with placebo over a two-year period. Patients treated with Fabhalta showed an annualized mean decline in estimated glomerular filtration rate (eGFR) of -3.0 mL/min/1.73 m² per year, compared with -5.7 mL/min/1.73 m² per year in the placebo group. The treatment also consistently showed benefits across multiple kidney-related outcomes, reinforcing its potential to slow disease progression.

The study also confirmed a safety profile consistent with previous findings. The most commonly reported side effects included abdominal pain, dizziness, and nausea. Because Fabhalta may increase the risk of serious infections caused by encapsulated bacteria, patients must receive appropriate vaccinations before starting treatment. The medicine is available only through a Risk Evaluation and Mitigation Strategy (REMS) program designed to help ensure its safe use.

Dr. Dana Rizk, Professor of Medicine in the Division of Nephrology at the University of Alabama at Birmingham and a member of the APPLAUSE-IgAN Steering Committee, said the approval highlights the importance of targeting the underlying disease mechanisms, including complement activation, to help preserve kidney function in patients with IgAN. Bonnie Schneider, Director and Co-Founder of the IgA Nephropathy Foundation, described the approval as an important milestone that offers renewed hope for patients and families affected by the progressive disease.

Novartis said the approval further strengthens its commitment to advancing treatments for kidney diseases and expanding options for people living with IgAN. Along with Fabhalta, the company's growing IgAN portfolio includes Vanrafia (atrasentan) and the investigational therapy zigakibart. Novartis also noted that it is supporting patient access through assistance programs, with nearly all eligible patients in the United States expected to pay $10 or less per month for Fabhalta.