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Novo Nordisk A/S. (12/5/17). "Press Release: Ozempic (semaglutide) Approved in the US". Bagsvaerd.

Region Region United States (USA)
Organisations Organisation Novo Nordisk A/S
  Group Novo Group (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Product Product Ozempic®
Person Person Krogsgaard Thomsen, Mads (Novo Nordisk 200702 CSO)
     


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."


Conference call

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.

About Ozempic®

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.

Further information
Media:
Katrine Sperling +45 4442 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com

Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Christina Kjær +45 3079 3009 cnje@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

Company announcement No 90 / 2017

   
Record changed: 2017-12-19

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