Ozempic oral tablet filed with EU for type 2 diabetes

Novo Nordisk announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Ozempic (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.

Ozempic oral was filed with the FDA in March 2019.

Please note that oral semaglutide has been submitted for regulatory approval in the US, the EU and Canada. Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once-daily, for the treatment of adults with type 2 diabetes. Ozempic® (semaglutide) is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that has been developed for the treatment of type 2 diabetes. Ozempic® was approved by the European Commission on 9 February 2018.