Ozempic® (semaglutide) recommended for approval by the European regulatory authorities
Bagsværd, Denmark, 15 December 2017 - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.
The CHMP recommends Ozempic®, the intended brand name for once-weekly semaglutide, to be indicated as monotherapy when metformin no longer provides sufficient treatment or is contraindicated and as an addition to other medicinal products for the treatment of diabetes. The indication also refers to specific sections of the label for study results with respect to combination with other diabetes medications, effects on glycaemic control, cardiovascular events and the populations studied. The label furthermore reflects the superior reduction in body weight achieved with Ozempic® relative to comparator treatments and the statistically significant reduction in diabetic nephropathy with Ozempic® relative to standard of care.
As an integral part of the approval, Novo Nordisk has committed to conduct post-approval safety studies including a long-term diabetic retinopathy outcome study. Furthermore, as required for all long-acting GLP-1 products approved in the EU, Ozempic® will be enrolled in the data collection for the registry of medullary thyroid carcinoma.
"We are very excited about the positive opinion for Ozempic® for treatment of people with type 2 diabetes in Europe, many of whom are still looking for new and more efficacious solutions to better manage their disease," said Mads Krogsgaard Thomsen, executive vice president and chief science officer. "We believe Ozempic®, with its unique clinical profile, has the potential to set a new standard for treatment of type 2 diabetes."
Novo Nordisk expects to receive final marketing authorisation from the European Commission in the first quarter of 2018.
Ozempic® (semaglutide) is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that has been developed for the treatment of type 2 diabetes. The review of Ozempic® is based on the SUSTAIN programme, a global clinical development programme that comprises eight phase 3a trials, encompassing more than 8,000 adults with type 2 diabetes. The phase 3a programme involves a broad range of people with type 2 diabetes, including some individuals with high cardiovascular risk profiles and people with and without renal disease.
Ozempic® was recently approved by the US Food and Drug Administration and is currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.
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Company announcement No 92 / 2017