The submission is based on the results from 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER programme, people treated with oral semaglutide demonstrated greater HbA1c reductions and weight loss in all completed head-to-head trials versus sitagliptin, empagliflozin, liraglutide and dulaglutide, at the end of the trials. Across the PIONEER trials, oral semaglutide had a safe and well-tolerated profile consistent with the GLP-1 receptor agonist (RA) class, with the most common adverse event being nausea.
"Achieving glycaemic control remains a challenge for people with type 2 diabetes, and despite availability of several oral treatment options, a high proportion do not achieve target blood sugar levels," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited about the regulatory filing of oral semaglutide in Europe, the first GLP-1 receptor agonist in a tablet, as we believe oral semaglutide has the potential to further improve the treatment of adults living with type 2 diabetes."
Oral semaglutide has now been submitted for regulatory approval in the US, the EU and Canada.
Further information
| Media: | ||
| Mette Kruse Danielsen | +45 4442 3883 | mkd@novonordisk.com |
| Ken Inchausti (US) | +1 609 240 9429 | kiau@novonordisk.com |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com |
| Valdemar Borum Svarrer | +45 3079 0301 | jvls@novonordisk.com |
| Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
| Kristoffer Due Berg (US) | +1 609 235 2989 | krdb@novonordisk.com |
Company announcement No 25 / 2019
