The European Commission has approved Novo Nordisk’s Rybelsus (semagludite) for treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control in conjunction with diet and exercise.

The approval was based on results from 10 clinical trials in which the drug demonstrated significant reductions in hemoglobin A1c compared with sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg (9.5 pounds) weight reduction after 52 weeks. 

Novo Nordisk expects to launch Rybelsus in the first EU countries in the second half of 2020.