Novo Nordisk files for US approval of semaglutide in weight management

4 December 2020

Danish diabetes care giant Novo Nordisk (NOV: N) today announced the submission of a new drug application (NDA) to the US Food and Drug Administration for subcutaneous semaglutide 2.4mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for chronic weight management.

A priority review voucher has been applied to the NDA, leading to an anticipated review time of six months from the submission date, according to standard FDA review timelines.

The potential indication is for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.

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