Novo Nordisk files for EU OK once-weekly semaglutide for type 2 diabetes

 Novo Nordisk today announced the submission of a label extension application to the European Medicines Agency (EMA) for the existing marketing authorisation for Ozempic^®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic^® 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 submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA_1c at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and 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. "With the 2.0 mg dose, more people with type 2 diabetes will be able to achieve treatment target”.

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