European marketing authorisation for Novo Nordisk’s Ozempic

Novo Nordisk expands biopharm business with Macrilen buy
Novo Nordisk HQ. Credit: Jens Lindhe

The European Commission has granted marketing authorisation to Novo Nordisk’s Ozempic (semaglutide) for the treatment of adults with type 2 diabetes.

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

The marketing authorisation applies to all 28 EU member states.

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 seeking approval of an updated Ozempic pen offering.

The 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.