In discussing the complexities of IgA nephropathy, Professor Dana Rizk, an Investigator and APPLAUSE-IgAN Steering Committee Member at the University of Alabama at Birmingham Division of Nephrology, highlights the evolving landscape of treatment options for this condition. IgA nephropathy, a rare and progressive disease characterized by kidney inflammation and proteinuria, affects approximately 25 individuals per million annually. Despite the current standard of care, up to 50% of patients with persistent proteinuria develop kidney failure within 10 to 20 years post-diagnosis, necessitating dialysis or transplantation.
The Phase III APPLAUSE-IgAN study is evaluating the efficacy and safety of the oral medication Fabhalta in adult IgA nephropathy patients. Fabhalta demonstrated a significant reduction in proteinuria compared to a placebo, with a favorable safety profile. In addition to Fabhalta, Novartis is committed to advancing the development of two additional therapies for IgA nephropathy with distinct mechanisms of action.
The approval of Fabhalta represents a significant milestone in the treatment of IgA nephropathy, offering new hope for patients and families impacted by the disease. Novartis also provides resources to help eligible patients access treatment, including personalized assistance with insurance coverage and financial support. The ongoing commitment of Novartis to rare renal diseases extends beyond IgA nephropathy, with a focus on developing innovative therapies to improve outcomes for patients with various kidney diseases.
