Posted by Michael Wonder on 27 Apr 2019
Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of type 2 diabetes
26 April 2019 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA 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 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 class, with the most common adverse event being nausea.
