Research & Development
Novo Nordisk's Ozempic receives marketing approval in the EU for the treatment of type 2 diabetes
9 February 2018 -

Global pharmaceutical company Novo Nordisk A/S (CPH:NOVOB) announced on Friday the grant by the European Commission (EC) of marketing authorisation for Ozempic (semaglutide) for the treatment of adults with type 2 diabetes.

Ozempic is a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) indicated as monotherapy when metformin is considered inappropriate due to intolerance or is contraindicated, as well as a as an addition to other medicinal products for the treatment of diabetes.

This marketing authorisation applies to all 28 EU member states.

According to the company, Ozempic has been approved in the EU for use in a multi-dose Ozempic pen, the latest generation of Novo Nordisk prefilled devices. However, Novo Nordisk intends to submit a variation application to the European Medicines Agency (EMA) seeking approval of an updated Ozempic pen offering.

This new pen offering will help facilitate reimbursement for patients with type 2 diabetes using Ozempic. The launch of Ozempic is expected to take place in the first EU countries in the second half of 2018 following the approval of the variation application for the updated pen offering.