Novo Nordisk has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Ozempic (oral semaglutide), for the treatment of type II diabetes.
The submission for the glucagon-like peptide-1 (GLP-1) analogue is based on results from 10 PIONEER clinical trials, which included 9,543 adults with type II diabetes and found that people treated with oral semaglutide demonstrated greater HbA1c reductions and weight loss in all completed head-to-head trials than those treated with Januvia (sitagliptin), Jardiance (empagliflozin), Victoza (liraglutide) and Trulicity (dulaglutide).
Across the PIONEER trials, Ozempic 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 II 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 II diabetes.”
The drug has now been submitted for regulatory approval in the US, the EU and Canada.