Novo Nordisk Submits New Drug Application to FDA for CagriSema Weekly Weight-Loss Injection

MT Newswires Live12-18 22:05

Novo Nordisk (NVO) said Thursday it has submitted a new drug application to the US Food and Drug Administration for once-weekly CagriSema injection in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction in adults with obesity or overweight and at least one weight-related comorbidity.

The application is based on the results of a 68-week, 3,417-patient phase 3 trial comparing CagriSema to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo and a 68-week, phase 3 trial evaluating CagriSema versus placebo in 1,206 patients with type 2 diabetes, the company said.

Patients treated with CagriSema achieved weight loss of 20.4% compared to 3% with placebo and 22.7% compared to 2.3% with placebo, respectively, the company said.

Safety data generated in the trials was comparable with other semaglutide medicines, the company said.

The FDA is expected to review the CagriSema application in 2026, the company said.

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