Bagsværd, Denmark, 26 April 2019 - Novo Nordisk today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for oral semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once-daily, for the treatment of adults with type 2 diabetes.

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

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