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Novartis receives Health Canada approval for Fabhalta® oral treatment for adults with C3G
Novartis Pharmaceuticals Canada Inc. ("Novartis Canada") announced today that Health Canada has granted a Notice of Compliance (NOC) for Fabhalta® (iptacopan capsules) for the treatment of adult patients with C3 glomerulopathy (C3G) to reduce proteinuria.1 The decision is supported by results from the Phase III APPEAR‑C3G trial, a multicentre, randomized, double‑blind, placebo‑controlled study.2,3
About this update from Novartis Ag
MONTREAL , May 1, 2026 /CNW/ - Novartis Pharmaceuticals Canada Inc. ("Novartis Canada") announced today that Health Canada has granted a Notice of Compliance (NOC) for Fabhalta ® (iptacopan capsules) for the treatment of adult patients with C3 glomerulopathy (C3G) to reduce proteinuria. 1 The decision is supported by results from the Phase III APPEAR‑C3G trial, a multicentre, randomized, double‑blind, placebo‑controlled study. 2,3 C3G is a chronic, rare kidney disorder linked to overactivation of the alternative pathway, part of the complement immune system. Overactivation of the alternative pathway activity leads to the C3 protein deposition in the glomeruli, resulting in inflammation, progressive injury and long-term loss of kidney function. Once diagnosed, kidney failure may occur in 30-50% of the patients within 10 years of their diagnosis. 4 Today, many patients continue to face uncertainty because current treatment options are limited to supportive care and broad immunosuppression, which may not target the root cause of the disease. 2,6,5 Fabhalta ® (iptacopan capsules) is an oral proximal complement inhibitor that targets Factor B, resulting in reduced activity of C3 and C5 convertases within the alternative pathway. By selectively inhibiting this pathway, Fabhalta ® is designed to reduce pathological complement activation implicated in C3G. 1,2 "C3G is a rare but significant kidney disease which commonly leads to end stage kidney disease, disproportionately affecting younger patients. Prior to this announcement, there were limited approved or effective therapies for this condition," said Dr. Louis-Philippe Girard, Nephrologist & Clinical Professor of Medicine, Medical Director of the Klassen Bellusco Precision Kidney Clinic. "This approval represents hope for patients who are afflicted with C3G. They will now have an oral targeted treatment for their disease which has minimal side effects. As care providers, we will seek to adopt this treatment in indicated patients so that we can alter the trajectory of kidney disease for patients with C3G in a very meaningful way." The clinical effectiveness, safety and cost‑effectiveness of Fabhalta ® are currently under review by Canada's Drug Agency (CDA) and Quebec's Institut national d'excellence en santé et en services sociaux (INESSS). 7 About Fabhalta ® (iptacopan capsules) Fabhalta ® is an oral Factor B inhibitor indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) to reduce proteinuria, supported by results from the Phase III APPEAR‑C3G clinical program. 2 Fabhalta ® is available in Canada through a controlled distribution program in which prescribers must confirm appropriate vaccination against encapsulated bacteria prior to treatment. 1 About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 500 people to serve the evolving needs of patients and the healthcare system and invests over $36 million in R&D yearly in the country. Reimagine medicine with us: Visit us at www.novartis.ca and connect with us on LinkedIn . References View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2026/01/c0567.html