Novo Nordisk A/S said the European Commission approved its oral diabetes drug Rybelsus for use in all EU member states and the U.K.
Rybelsus, or oral semaglutide, received marketing authorization for the treatment of adults with insufficiently controlled type 2 diabetes to improve blood sugar control in addition to diet and exercise. Rybelsus is a once-daily diabetes drug in tablet form.
The Bagsvaerd, Denmark-based drugmaker said the approval was supported by 10 clinical trials, dubbed Pioneer, which showed Rybelsus' safety and effectiveness.
The medicine is expected to be launched in the first EU countries in the second half of 2020.
Rybelsus was approved by the U.S. Food and Drug Administration on Sept. 20, 2019.