Novo Nordisk A/S: Ozempic® (semaglutide) approved in the EU for the treatment of type 2 diabetes
Bagsværd, Denmark, 9 February 2018 - Novo Nordisk today 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. 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.
"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," said Mads Krogsgaard Thomsen, executive vice president and chief science officer. "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."
Ozempic® (semaglutide) is a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that has been developed for the treatment of type 2 diabetes. The approval of Ozempic® is based on the SUSTAIN programme, a global clinical development programme that comprised eight phase 3a trials, encompassing more than 8,000 adults with type 2 diabetes. The phase 3a programme involved a broad range of people with type 2 diabetes, including some with high cardiovascular risk profiles and people with and without renal disease. Ozempic® was approved by the US FDA on 5 December 2017 and by Health Canada on 9 January 2018.
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Company announcement No 12 / 2018