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 HbA 1c 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.
About Rybelsus ®
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.
Further information
| Media: | ||
| Mette Kruse Danielsen | +45 3079 3883 | mkd@novonordisk.com |
| Ken Inchausti (US) | +1 609 240 9429 | kiau@novonordisk.com |
| Investors: | ||
| Daniel Muusmann Bohsen | +45 3075 2175 | dabo@novonordisk.com |
| Valdemar Borum Svarrer | +45 3079 0301 | jvls@novonordisk.com |
| Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
| Mark Joseph Root | +45 3079 4211 | mjhr@novonordisk.com |
| Kristoffer Due Berg (US) | +1 609 235 2989 | krdb@novonordisk.com |
Company announcement No 21 / 2020
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