Novo Nordisk Files FDA Application For Weekly Combination Obesity Shot

Novo Nordisk A/S (NYSE:NVO) on Thursday submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema.

The application covers CagriSema for use with a reduced-calorie diet and increased physical activity to treat obesity or overweight in the presence of at least one weight-related comorbid condition.

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.

The application is based on results from REDEFINE 1, a 68-week, phase 3 trial, and REDEFINE 2 phase 3 trial.

The REDEFINE 1 trial found that, regardless of whether patients remained on treatment, patients treated with CagriSema achieved a 20.4% weight loss at 68 weeks, compared with 3.0% for the placebo group.

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CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group when evaluating the treatment effect if all patients stayed on treatment.

91.9% of participants taking CagriSema achieved a body weight reduction of greater than or equal to 5%, compared to 31.5% for the placebo group.

In addition, a supportive secondary analysis showed that about half (54%) of trial participants with CagriSema reached the threshold for non-obesity at week 68 vs. 11.1% in the placebo group.

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

CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program).

NVO Price Action: Novo Nordisk shares were down 0.28% at $47.63 at the time of publication on Thursday, according to Benzinga Pro data.

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