RTTNews | Dec 29, 2020 06:52AM EST

06:51 Tuesday, December 29, 2020 (RTTNews.com) - Danish pharmaceutical company Novo Nordisk A/S (NVO) said Tuesday it has submitted a label extension application to the European Medicines Agency or EMA for the existing marketing authorisation for Ozempic to introduce a new dose of 2.0 mg.

Ozempic, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults.

The application submission is based on the results from the SUSTAIN FORTE trial that included 961 people with type 2 diabetes requiring treatment intensification.

In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. Both doses of semaglutide appeared safe and well-tolerated in the trial.

The most common adverse events in the trial were gastrointestinal, with the vast majority being mild to moderate that diminished over time and were consistent with the GLP-1 receptor agonist class.

Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.

"Following the announcement of the headline results in November, we have expeditiously prepared the submission file. The submission in the EU represents an important milestone for people living with type 2 diabetes who have poor glycaemic control and need treatment intensification" said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk.

Read the original article on RTTNews ( https://www.rttnews.com/3156526/novo-nordisk-files-for-eu-approval-of-semaglutide-2-0-mg-for-type-2-diabetes-quick-facts.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2020 RTTNews.com All Rights Reserved