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Novartis receives Health Canada approval for VANRAFIA™ (atrasentan tablet) for proteinuria reduction in adults with primary immunoglobulin A nephropathy (IgAN) - The Malaysian Reserve
Categories: PR Newswire

Novartis receives Health Canada approval for VANRAFIA™ (atrasentan tablet) for proteinuria reduction in adults with primary immunoglobulin A nephropathy (IgAN)

  • VANRAFIATM (atrasentan tablets) is indicated to reduce proteinuria in adults with IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.¹
  • In the Phase III ALIGN study, VANRAFIATM demonstrated a statistically significant reduction in 24-hour UPCR at Week 36 compared with placebo.¹

MONTREAL, July 13, 2026 /CNW/ — Novartis Pharmaceuticals Canada Inc. (“Novartis Canada”) announced today that Health Canada has granted approval for VANRAFIATM (atrasentan tablets) for proteinuria reduction in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.¹

IgAN is an autoimmune kidney disease that occurs when clumps of immunoglobulin A and antibodies are deposited in the kidneys, causing inflammation and kidney damage which leads to blood and protein leaking into the urine.2 

The Health Canada authorization is based on a prespecified interim analysis results at 36 weeks of the Phase III ALIGN study, a randomized, double-blind, placebo-controlled study in adults ≥ 18 years with biopsy-proven primary IgAN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² and total urine protein ≥ 1 g/day who were on a stable dose of maximally tolerated renin-angiotensin system inhibitor therapy.¹

About VANRAFIATM

VANRAFIATM (atrasentan tablets) is a potent and highly selective Endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). ¹ VANRAFIATM is supplied as a 0.75 mg film-coated tablet and is administered orally once daily. 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

  1. VanrafiaTM (atrasentan tablets) Product Monograph. July 2, 2026.
  2. National Institute of Diabetes and Digestive and Kidney Diseases. IgA Nephropathy – NIDDK. Available at: NIDDK IgA Nephropathy overview. Last accessed June 22, 2026.

SOURCE Novartis Pharmaceuticals Canada Inc.

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