Bagsværd, Denmark, 5 December 2017 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide injection). Ozempic® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Ozempic®, the approved brand name for once-weekly semaglutide in the US, is a glucagon-like peptide 1 (GLP-1) receptor agonist. The approval of Ozempic® is based on the results from the SUSTAIN clinical trial programme and follows a positive recommendation from an FDA Advisory Committee meeting on 18 October 2017. In people with type 2 diabetes, Ozempic® produced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100. Furthermore, in the trials, treatment with Ozempic® resulted in statistically significant reductions in body weight. Ozempic® demonstrated a safe and well-tolerated profile across the SUSTAIN programme with the most common adverse event being mild to moderate nausea, which diminished over time.
Ozempic® is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched in the Ozempic® Pen, the latest generation of Novo Nordisk prefilled devices.
Novo Nordisk will, as part of the post-approval requirements, conduct a paediatric trial in adolescents under 18 years of age and will add Ozempic® to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all other long-acting GLP-1 products.
"We are very excited about the first approval of Ozempic® and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018," said Mads Krogsgaard Thomsen, executive vice president and chief science officer. "Type 2 diabetes is a complex disease, but with the unique clinical profile of Ozempic®, we believe it has the potential to set a new standard for the treatment of the disease."
On 6 December 2017 at 12.00 pm CET, corresponding to 6.00 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.
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 with high cardiovascular risk profiles and people with and without renal disease.
Ozempic® is currently under review by several regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
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Company announcement No 90 / 2017