Novo Nordisk files for FDA approval of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes.

Novo Nordisk has announced the submission of a label expansion application to the FDA for the existing marketing authorisation for Ozempic, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic is currently approved in the US in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. The submission follows the application on 29 December 2020 for label extension to the European Medicines Agency (EMA). The submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared to have safe and well-tolerated profiles. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.