Novo Nordisk files for EU approval of oral semaglutide for type 2 diabetes

Danish diabetes care giant Novo Nordisk (NOV: N) says it has filed a Marketing Authorization Application (MAA) to the European Medicines Agency 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 program, 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 glycemic 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, adding: "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."