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."
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.
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