Novo Nordisk announces submission of MAA to EU for oral semaglutide for the treatment of type 2 diabetes.
M2 PHARMA-April 29, 2019-Novo Nordisk announces submission of MAA to EU for oral semaglutide for the treatment of type 2 diabetes
(C)2019 M2 COMMUNICATIONS
Global health care company Novo Nordisk A/S (CPH:NOVOB) announced on Friday the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (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.
Reportedly, this 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. Also, 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.
Now, oral semaglutide has been submitted for regulatory approval in the US, the EU and Canada.
((Comments on this story may be sent to email@example.com))
|Printer friendly Cite/link Email Feedback|
|Date:||Apr 29, 2019|
|Previous Article:||Novo Nordisk announces receipt of positive opinion from CMPH for Esperoct for the treatment of haemophilia A in Europe.|
|Next Article:||Regeneron awarded US FDA approval for Praluent for the prevention of heart attack, stroke and unstable angina.|