Rybelsus, which is currently being reviewed by regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency
Novo Nordisk secures marketing authorization for Rybelsus in Europe (Credit: Sébastien Bertrand/Wikipedia.)
Denmark-based Novo Nordisk has obtained the European Commission (EC) approval to market its Rybelsus (oral semaglutide), intended for the treatment of type 2 diabetes.
The pharmaceutical firm said that its Rybelsus has been approved as an adjunct to diet and exercise to improve glycaemic control in adults with insufficiently controlled type 2 diabetes, and the marketing authorisation is valid in all 27 member states in the European Union and the UK.
Novo Nordisk Thomsen executive vice president and chief science officer Mads Krogsgaard Thomsen 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.
“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.”
Rybelsus has already been approved in the US, Switzerland and EU
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1, and is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist, said the company.
The European regulatory approval is based on the results from 10 PIONEER clinical trials, in which Rybelsus has significantly reduced HbA1c vs sitagliptin, empagliflozin and liraglutide and helped reduce the weight of up to 4.3 kg.
Rybelsus showed a safe and well-tolerated profile in the PIONEER clinical trials programme, and the most common adverse event is mild to moderate nausea which diminished over time.
Novo Nordisk intends to roll out the Rybelsus, which is currently being reviewed by regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency, in the second half of 2020, in the first EU countries.
Also, the drug has been approved in the US, Switzerland and EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.