Posted by Michael Wonder on 06 Apr 2020
Rybelsus (oral semaglutide) approved for the treatment of adults with type 2 diabetes in the EU
4 April 2020 - Novo Nordisk today 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 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.
