Novo Nordisk announced that the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a label extension 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 positive opinion is based on the results from the SUSTAIN FORTE trial. 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 to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal. Novo Nordisk expects a final approval by the European Commission within approximately two months, and Ozempic? 2.0 mg will be launched in the EU in the first half of 2022. The label expansion for semaglutide 2.0 mg is under regulatory review in the US.