Breaking: Health Canada Authorizes Wegovy® as First Treatment for Non-Cirrhotic MASH

In a landmark decision for liver health, Health Canada has granted Notice of Compliance with Conditions (NOC/c) for Wegovy® (semaglutide injection). This authorization makes it the first and only treatment available in Canada specifically for adults with non-cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) who have moderate to advanced liver fibrosis.

This approval marks a significant turning point in the management of liver disease, offering a targeted pharmaceutical option for a condition that previously relied heavily on lifestyle management alone.

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Key Takeaways

• First Mover: Wegovy® is the first approved treatment in Canada for MASH.
• Target Patient: Adults with non-cirrhotic MASH and stage F2 or F3 fibrosis.
• Clinical Basis: Approval is based on positive results from the Phase 3 ESSENCE trial.
• Mechanism: Semaglutide works by reducing liver inflammation and improving metabolic function.

What is MASH (formerly NASH)?

Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH, is a serious, progressive liver disease. It occurs when excess fat builds up in the liver, leading to inflammation and cellular damage.

If left untreated, MASH can progress to advanced fibrosis (scarring) and eventually cirrhosis, liver failure, or liver cancer. Until now, Canadian patients had no approved medication to directly target the disease, making this authorization a critical development in hepatology.

Clinical Evidence: The ESSENCE Trial

The conditional approval by Health Canada is grounded in the promising data from the ongoing Phase 3 ESSENCE trial. The study evaluated the efficacy of semaglutide 2.4 mg in improving liver histology.

Key findings demonstrated that patients treated with Wegovy® showed statistically significant improvements in:

• Resolution of Steatohepatitis: Reduction of liver fat and inflammation without worsening of fibrosis.
• Fibrosis Improvement: Regression of liver scarring in patients with stage F2 and F3 fibrosis.

Impact on the Canadian Healthcare Landscape

Dr. Alnoor Ramji, Clinical Professor of Medicine at the University of British Columbia, highlighted the urgency of this approval, stating that MASH is often a "silent disease" that goes undiagnosed until advanced stages.

With this authorization, Novo Nordisk reinforces its dominance in the metabolic space, expanding semaglutide's utility beyond Type 2 Diabetes (Ozempic®) and Obesity (Wegovy®) into serious liver disease.

Looking Ahead

As this is a conditional marketing authorization, Novo Nordisk will continue to provide data from the ongoing ESSENCE trial to confirm the long-term clinical benefits. However, for patients currently struggling with moderate to advanced fibrosis due to MASH, this represents immediate hope.

Stay tuned to E-PharmaTimes for updates on pricing, insurance coverage, and availability in Canadian pharmacies.

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Disclaimer: The content provided on this blog is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.