Novartis Discovered First-of-its-Kind Fabhalta (iptacopan) Immunoglobulin A Nephropathy
Novartis has introduced Fabhalta (iptacopan), a first-of-its-kind treatment designed to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
Fabhalta specifically targets the alternative complement pathway, which, when overly activated in the kidneys, is believed to contribute to IgAN's pathogenesis.
IgAN is a rare and progressive disease in which the immune system targets the kidneys, causing glomerular inflammation and proteinuria. Each year, about 25 people per million globally receive a new diagnosis of IgAN.
The disease progression and treatment responses vary widely among patients, with up to 50% of those with persistent proteinuria advancing to kidney failure within 10 to 20 years, often necessitating dialysis or kidney transplantation.
The ongoing Phase III APPLAUSE IgAN study is assessing the efficacy and safety of twice-daily Fabhalta (200 mg) compared to a placebo in adult IgAN patients already on stable renin-angiotensin system inhibitor therapy, with or without SGLT2i.
At the 9-month interim analysis, Fabhalta demonstrated a significant 38 percent reduction in proteinuria versus placebo, with a 44 percent reduction from baseline, compared to just 9 percent in the placebo group. The treatment effect was consistent across various subgroups, and Fabhalta exhibited a favourable safety profile, with common adverse reactions including upper respiratory tract infection, lipid disorder, and abdominal pain.
