- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Liraglutide Submitted for Regulatory Approval as Obesity Treatment
Drug is indicated for type-2 diabetes as Victoza (December 20)
A new drug application (NDA) has been submitted to the FDA for a 3-mg dose of liraglutide (Novo Nordisk), a once-daily human glucagon-like peptide-1 (GLP-1) analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or who are overweight with comorbidities.
The regulatory submission includes data from the phase III SCALE clinical trial program, which involved more than 5,000 people with obesity (body mass index [BMI] ≥ 30 kg/m2) or who were overweight (BMI ≥ 27 kg/m2) with comorbidities. In addition to the data from the SCALE program, findings from earlier development phases and data related to the use of liraglutide in patients with type-2 diabetes were also included in the submission.
Data from the SCALE program demonstrated that liraglutide 3 mg, in combination with diet and exercise, induces and maintains weight loss while significantly improving obesity-related comorbidities, such as hypertension, dyslipidemia, and sleep apnea. Further, in people with obesity and type-2 diabetes or prediabetes, clinical trials have demonstrated that liraglutide 3 mg significantly improves glycemic control in addition to lowering weight.
Liraglutide 3 mg is a once-daily GLP-1 analogue with 97% homology to naturally occurring human GLP-1. Like human GLP-1, liraglutide 3 mg regulates appetite by increasing feelings of fullness and by reducing feelings of hunger, thereby allowing people to feel satisfied with eating less. GLP-1 also plays a role in maintaining normal blood glucose levels.
Liraglutide is currently approved and marketed at lower doses (1.2 and 1.8 mg once-daily, as well as 0.9 mg in Japan) for the treatment of type-2 diabetes under the brand name Victoza (Novo Nordisk). Victoza is not approved for weight management and should not be prescribed for that indication.
Source: Novo Nordisk; December 20, 2013.