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Novo Nordisk Submits New Drug Application To U.S. FDA For Once-Weekly Cagrisema Injection

Benzinga·12/18/2025 13:19:28
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Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition.1 CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg, and the GLP-1 receptor agonist, semaglutide 2.4 mg.2 If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment.