European approval for Novo’s Rybelsus to control blood sugar in type 2 diabetes

pharmafile | April 6, 2020 | News story | Sales and Marketing |  Novo Nordisk, Rybelsus, diabetes, pharma 

The European Commission has greenlighted Novo Nordisk’s Rybelsus (oral semaglutide) as an adjunct to diet and exercise to improve glycaemic control in adults with insufficiently controlled type 2 diabetes, the manufacturer confirmed.

Billed as the “first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist”, patients taking Rybelsus showed weight loss of up to 4.3kg, and the therapy was well-tolerated, with the most common associated adverse event being mild to moderate nausea.

Data derived from the PIONEER programme of ten clinical trials demonstrated that Novo’s drug proved itself superior in reducing blood glucose levels (HbA1C) after 52 weeks compared to sitagliptin, empagliflozin and liraglutide.

“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,” commented 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.”

According to Novo, the first EU countries can expect availability of the drug I the second half of the year.

Matt Fellows