Novo Nordisk has announced that the European Commission (EC) has granted marketing authorization 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 authorization applies to all 27 European Union member states and the United Kingdom.
Based on results from 10 PIONEER clinical trials
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.
“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,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer. “Based on its strong clinical profile, we believe Rybelsus has the potential to set a new standard for the treatment of type 2 diabetes, as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”
The launch of Rybelsus is expected to take place in the first EU countries in the second half of 2020.
Photo: Novo Nordisk headquarter