Novo Nordisk applies to EMA for approval of oral semaglutide

Following submission for regulatory approval in Canada and the US, and on the back of results from 10 PIONEER clinical trials, Novo Nordisk has now submitted a Marketing Authorisation Application to the European Medicines Agency for oral semaglutide, a glucagon-like peptide-1 analogue in a one-a-day tablet, for the treatment of adults with type 2 diabetes.
9,543 adults with type 2 diabetes took part in the PIONEER trials. Those treated with oral semaglutide demonstrated greater HbA1c reductions and weight loss in all completed trials compared with sitagliptin, empagliflozin, liraglutide and dulaglutide, at the end of the trials. Oral semaglutide had a safe and well-tolerated profile across the board, consistent with the GLP-1 receptor agonist class, with nausea being the most common adverse event.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “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. 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.”