Regulatory Affairs

Novo Nordisk’s Ozempic secures European approval for type 2 diabetes

Published 12 February 2018

Novo Nordisk’s Ozempic (semaglutide) has secured marketing authorization from the European Commission (EC) 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. However, 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.

Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: "We are very excited about the approval of Ozempic in the EU, as we believe it has the potential to set a new standard for the treatment of type 2 diabetes.

"Type 2 diabetes is a complex disease and the strong clinical profile of Ozempic provides a much needed treatment option for people looking for efficacious solutions to manage their disease."

Source: Company Press Release