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

Novo Nordisk announced the submission of a label extension application to the European Medicines Agency (EMA) 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 EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults. 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 at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. 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.