In a statement by Professor Dana Rizk, an Investigator and APPLAUSE-IgAN Steering Committee Member at the University of Alabama at Birmingham Division of Nephrology, she emphasized the complex and evolving nature of IgA nephropathy, posing challenges to its effective treatment. The disease, characterized by the immune system’s attack on the kidneys, often leading to glomerular inflammation and proteinuria, affects approximately 25 individuals per million globally each year. With up to 50% of IgAN patients with persistent proteinuria progressing to kidney failure within 10 to 20 years post-diagnosis, the standard of care may not always suffice. The availability of targeted therapies with various mechanisms of action offers a more personalized treatment approach for patients.
The ongoing Phase III APPLAUSE-IgAN study assessed the efficacy and safety of oral Fabhalta compared to a placebo in adult IgAN patients using a stable dose of renin-angiotensin system (RAS) inhibitor therapy. Fabhalta demonstrated a 44% reduction in proteinuria at 9 months relative to baseline, with a favorable safety profile. Novartis, celebrating the FDA approval of Fabhalta for IgA nephropathy, expresses its commitment to advancing rare renal disease care and continues to develop innovative therapies like atrasentan and zigakibart for IgAN.
Bonnie Schneider, Director and Co-Founder of the IgAN Foundation, shared her personal experience as a parent of a child with IgAN and expressed optimism about the new treatment options like Fabhalta. In addition to providing innovative treatments for rare renal diseases, Novartis offers resources to help eligible patients access their treatments through the Novartis Patient Support program.
The APPLAUSE-IgAN study, a Phase III multicenter trial, aims to evaluate the efficacy and safety of Fabhalta in 518 adult primary IgAN patients. Fabhalta is indicated for adults with primary IgAN at risk of rapid disease progression, with its approval based on reducing proteinuria. Key safety information includes the risk of serious infections by encapsulated bacteria and the need for specific vaccinations before treatment with Fabhalta. Please refer to the full Prescribing Information for detailed safety guidance.
Novartis, with a rich history in nephrology and a comprehensive renal R&D portfolio, continues its dedication to providing transformative therapies for kidney diseases. The FDA approval of Fabhalta marks a significant milestone, with ongoing studies exploring its potential in other rare diseases. For additional information on Fabhalta and Novartis’s efforts in rare kidney diseases, please visit the Novartis website.
