Data from Pharmawand - Curated by EPG Health - Date added 12 February 2018
Novo Nordisk announced that the European Commission (EC) has granted 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, and as an addition to other medicinal products for the treatment of diabetes.
The marketing authorisation applies to all 28 European Union member states. The label reflects the superior and sustained reductions in HbA1c and body weight achieved with Ozempic relative to comparator treatments, cardiovascular benefits and the statistically significant reduction in diabetic nephropathy with Ozempic relative to standard of care. Ozempic has been approved in the EU for use in a multi-dose Ozempic pen, the latest generation of Novo Nordisk prefilled devices.
Novo Nordisk intends to submit a variation application to the European Medicines Agency (EMA) 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.