Bagsværd, Denmark, 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 (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.
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1. Rybelsus is approved in the US, Switzerland and EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg.
Rybelsus is currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.
|Mette Kruse Danielsen||+45 3079 firstname.lastname@example.org (mailto:email@example.com)|
|Ken Inchausti (US)||+1 609 240 firstname.lastname@example.org (mailto:email@example.com)|
|Daniel Muusmann Bohsen||+45 3075 firstname.lastname@example.org (mailto:email@example.com)|
|Valdemar Borum Svarrer||+45 3079 firstname.lastname@example.org (mailto:email@example.com)|
|Ann Søndermølle Rendbæk||+45 3075 firstname.lastname@example.org (mailto:email@example.com)|
|Mark Joseph Root||+45 3079 firstname.lastname@example.org (mailto:email@example.com)|
|Kristoffer Due Berg (US)||+1 609 235 firstname.lastname@example.org (mailto:email@example.com)|
Company announcement No 21 / 2020
- PR200404_Rybelsus_approval_EU (https://ml-eu.globenewswire.com/Resource/Download/4a61f1c9-f8ce-4d0d-a063-14cc4f66e465)