Wegovy cleared in Canada to treat fatty liver disease MASH
Conditional OK covers those with moderate to advanced fibrosis
Health Canada has conditionally approved Novo Nordisk’s Wegovy (semaglutide) to treat metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease.
The weekly under-the-skin injection therapy, given at a dose of 2.4 mg, is indicated specifically for MASH patients with moderate to advanced liver scarring (fibrosis).
“This approval is a major milestone, marking the only Health Canada approved treatment option for eligible Canadians living with MASH,” Vince Lamanna, president of Novo Nordisk Canada, said in a company press release. “It further builds on the growing evidence demonstrating the benefits of semaglutide across a range of chronic conditions and has the potential to help even more Canadian patients and their families.”
The decision comes nearly eight months after Novo Nordisk filed a regulatory application seeking approval for Wegovy in the country. Conditional approval enables market access based on early evidence of the therapy’s efficacy, with full approval contingent upon Novo Nordisk providing confirmatory clinical trial data of its benefits.
“Our community has long awaited an approved treatment option for MASH,” said Michael Betel, the president and founder of the Canadian Fatty Liver Alliance. “This approval brings renewed hope to people living with this serious condition and reflects a significant step forward in improving care and outcomes for Canadians living with MASH and their families.”
Approvals sought in other countries
Wegovy’s conditional approval for MASH in Canada follows a similar decision in the U.S. in August. Health authorities in the European Union and Japan are reviewing approval applications.
Wegovy is approved in Canada as a once-weekly treatment for obesity and to reduce the risk of heart attacks in adults with cardiovascular disease who are overweight or obese. Its active ingredient, semaglutide, is also cleared for use in the country for managing type 2 diabetes in two formulations: a weekly injection, Ozempic, and a daily oral tablet, Rybelsus.
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease, involves fat buildup in the liver in people with metabolic conditions like diabetes, high blood pressure, elevated fats in the blood, or obesity. In some cases, it can progress to MASH, where inflammation and fibrosis damage the liver, impair its function, and boost the risk of cirrhosis (irreversible liver scarring), liver cancer, and death.
MASH prevalence in Canada is projected to increase from 5.2% to 6.5% by 2030, while deaths for people with the condition are expected to double, according to Novo Nordisk.
“Having treatment options in this patient population is extremely needed because the disease affects a large population, has a high risk of severe complications like liver cirrhosis and cancer, and lacks effective treatments,” said Mark Swain, MD, a liver disease specialist and professor of medicine at the University of Calgary. “Furthermore, it is often diagnosed late due to a lack of early symptoms.”
Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist, meaning it mimics the effects of the hormone GLP-1, which normally helps the body control blood sugar and appetite.
Health Canada’s decision was supported by positive findings from the first part of the Phase 3 ESSENCE clinical trial (NCT04822181). The data covered 800 people with MASH and moderate to advanced fibrosis who received Wegovy (2.4 mg) or a placebo for approximately 1.5 years.
Results showed that Wegovy significantly outperformed the placebo at resolving MASH without worsening fibrosis (62.9% vs. 34.3% of patients), lessening liver fibrosis without worsening liver inflammation (36.8% vs. 22.4%), and easing both liver fibrosis and inflammation (32.7% vs. 16.1%).
“In clinical trials, semaglutide 2.4 mg showed [not only to] stop liver fibrosis from worsening but was shown to reverse fibrosis in a significant proportion of people living with MASH,” said Giada Sebastiani, MD, a clinician scientist and hepatologist at McGill University Health Centre, in Canada.
The second part of ESSENCE is evaluating whether Wegovy significantly alters the risk of liver-related clinical events, including cirrhosis, versus a placebo, after about 4.5 years. This part of the study is scheduled to conclude in 2029.
Wegovy’s approval for MASH “not only addresses a significant unmet need, but up until now we’ve had no pharmacological options in Canada for this often-debilitating disease,” Sebastiani said. “I could not be more excited for my patients, their families, and the MASH community.”
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