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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


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.

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Publication:M2 Pharma
Date:Apr 29, 2019
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