GLP-1 receptor agonist approved by FDA for treatment of T2DMDec. 12, 2017 - news
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.