GLP-1 receptor agonist approved by FDA for treatment of T2DM

Based on the results of the SUSTAIN trial, semaglutide is approved by the FDA for the treatment of T2DM patients.

FDA approved the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, a once-weekly injection available in two therapeutic dosages: 0.5 and 1 mg. It is indicated as an adjunct to diet and exercise to improve glycemic control in T2DM patients.

The SUSTAIN programme, consisting of >8000 patients with a broad range of profiles, showed that semaglutide resulted in significant reductions in HbA1c and body weight compared with placebo, sitagliptin, exenatide-extended release and insulin glargine in T2DM patients. Semaglutide was safe and well-tolerated and the most common adverse event was mild to moderate nausea, which diminished over time.

A pediatric trial in adolescents under 18 years of age will be conducted as part of the post-approval requirements.

Source: press release Novo Nordisk, 5 December, 2017