Health Canada accepts semaglutide 2.4 mg, a GLP-1RA treatment for MASH, as a supplemental New Drug Submission under the Priority Review Policy

• It is estimated that by 2030 the prevalence of MASH (Metabolic Dysfunction-Associated Steatohepatitis) in the Canadian general population will increase from 5.2% to 6.5%.¹ 
• Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant.²

MISSISSAUGA, ON, May 2, 2025 /CNW/ - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the Priority Review policy, its supplemental new drug submission (sNDS) for semaglutide 2.4 mg, a once weekly therapy for people living with MASH (metabolic dysfunction-associated steatohepatitis).

"Semaglutide 2.4 mg represents a therapeutic advancement for patients living with MASH, addressing a critical unmet medical need," says Vince Lamanna, President of Novo Nordisk Canada Inc. "Health Canada's acceptance of the Semaglutide 2.4 mg submission for review brings us one step closer to providing the first treatment option for eligible people living with MASH."

About semaglutide 2.4 mg
Semaglutide injection 2.4 mg is currently approved by Health Canada for chronic weight management and non-fatal myocardial infarction (MI) risk reduction in adults with established cardiovascular disease and BMI ≥ 27 kg/m².³

Semaglutide is not approved in Canada for the treatment of MASH. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation.

About Metabolic Dysfunction-Associated Steatohepatitis (MASH)  
MASH is a chronic, progressive metabolic disease affecting the liver, which can be potentially life-threatening if not properly managed.^4,5 Among people who are living with overweight or obesity, approximately one in three also have MASH.⁶ Excess fat can build up in the liver, which, over time, can lead to inflammation and severe scarring of the liver.⁷ People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in a delayed diagnosis.⁸ It is estimated that by 2030 the prevalence of MASH in the Canadian general population will increase from 5.2% to 6.5%.¹ In Canada, the number of deaths are expected to double in people living with MASH by 2030.¹

About Novo Nordisk 
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.ca, Facebook, Instagram, X, LinkedIn and YouTube.

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^1	Swain M et al. CMAJ Open 2020;8:E429-E436. CMA open, 8(2), June 2020
^2	Fichez J, Mouillot T, Vonghia L, et al. Non-invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials. JHEP Reports. 2025;7(4);101351. doi:10.1016/j.jhepr.2025.10135
^3	Novo Nordisk Canada Inc. (2025, April 8). Wegovy^®Product Monograph. Wegovy-product-monograph-v3.pdf
^4	Ilan Y. Analogy between non-alcoholic steatohepatitis (NASH) and hypertension: a stepwise patient-tailored approach for NASH treatment. Ann Gastroenterol. 2018;31:296-304. doi:10.20524/aog.2018.0248
^5	Tesfay M, Goldkamp JW, Neuschwander-Tetri BA. NASH: the emerging most common form of chronic liver disease. Mo Med. 2018;115:225-229
^6	Quek J, Chan KE, Wong ZY, et al. Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023;8:20-30. doi: 10.1016/S2468-1253(22)00317-X
^7	National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts of NAFLD & NASH. Accessed November 7, 2024. Available at: https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
^8	Allen AM, Charlton M, Cusi K, et al. Guideline-based management of metabolic dysfunction-associated steatotic liver disease in the primary care setting. Postgrad Med. 2024;136:229-245. doi:10.1080/00325481.2024.2325332

SOURCE Novo Nordisk Canada Inc.

Contact for further information: Novo Nordisk Canada: Jaclyn Crawford, 647-201-6817, [email protected]; Kate Hanna, 905-301-7334, [email protected]