EU approves Rybelsus for type 2 diabetes.- Novo Nordisk

Novo Nordisk announced that the European Commission (EC) has granted marketing authorisation for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. The marketing authorisation applies to all 27 European Union member states and the United Kingdom. Rybelsus is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist.

The approval is based on the results from 10 PIONEER clinical trials, in which Rybelsus after 52 weeks demonstrated statistically significant reductions in HbA1c vs sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg weight reduction. Across the PIONEER programme, Rybelsus demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished over time. The launch of Rybelsus is expected to take place in the first EU countries in the second half of 2020.