Novo Nordisk has announced that Rybelsus (oral semaglutide) has been approved for the adult patients suffering with type 2 diabetes by the European Union. The drug has been approved in patients with insufficiently controlled diabetes mellitus, administered as an adjuvant to diet and exercise. The company has clarified that this approval is applicable to the 27 European Union nations and the United Kingdom.
Rybelsus is a oral glucagon-like-peptide-1 (GLP-1) agonist.
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The approval is based on PIONEER clinical trials. In the studies, Rybelsus showed significant improvement in terms of HbA1c vs sitagliptin, empagliflozin and liraglutide and 4.3 kg of weight reduction.
Mads Krogsgaard Thomsen, executive vice president and chief science officer said “We are very excited about the approval of Rybelsus® as we can now offer people in Europe living with type 2 diabetes the first and only GLP-1 in a tablet.”
The drug has been already approved in the US, and Switerzland. The product is under review in Japan.