Professor Dana Rizk, an Investigator and APPLAUSE-IgAN Steering Committee Member at the University of Alabama at Birmingham Division of Nephrology, acknowledged the challenges posed by the heterogeneous and progressive nature of IgA nephropathy. He emphasized the evolving treatment landscape for the disease, particularly highlighting the crucial role of complement activation in IgA nephropathy and the availability of targeted treatment options for patients.
IgA nephropathy is a rare and progressive disease where the immune system attacks the kidneys, leading to glomerular inflammation and proteinuria. Around 25 people per million worldwide are newly diagnosed with IgA nephropathy each year. The disease progression and treatment response can vary significantly among individuals, with up to 50% of patients experiencing kidney failure within 10 to 20 years of diagnosis despite current standard care.
The approval of Fabhalta, a first-in-class medicine for IgA nephropathy, marks an important milestone in the effort to provide new treatment options for patients in urgent need. Novartis, the manufacturer of Fabhalta, is committed to advancing care for rare renal diseases and is actively developing other therapies, such as atrasentan and zigakibart, for IgA nephropathy.
The ongoing Phase III APPLAUSE-IgAN study has shown promising results for Fabhalta, with a significant reduction in proteinuria at 9 months compared to placebo. The therapy demonstrated a favorable safety profile, although it may lead to serious infections that require specific vaccinations as part of the Risk Evaluation and Mitigation Strategy (REMS).
In addition to innovative medicines, Novartis offers support programs to help eligible patients access treatment and navigate insurance coverage. The company is dedicated to improving the lives of individuals with kidney diseases through research and development of novel therapies.
Please refer to the full prescribing information and safety details for Fabhalta before use. For further inquiries or assistance, patients or healthcare providers can contact Novartis Patient Support at 1-833-993-2242 or visit support.fabhalta.com.
The APPLAUSE-IgAN study (NCT04578834) is a Phase III trial evaluating the efficacy and safety of Fabhalta in adult primary IgA nephropathy patients. The study aims to assess proteinuria reduction and renal function over a 24-month period.
Novartis remains committed to addressing rare kidney diseases and strives to provide innovative solutions that extend and improve the lives of patients. For more information about Novartis and its initiatives in nephrology, visit their official website and connect with them on various social media platforms.
