Application to EMA filed for the approval of oral semaglutide

It has been announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for oral semaglutide.

This is 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 (made by Novo Nordisk) is based on the results from 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the 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 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.