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Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes

PLAINSBORO, N.J., Dec. 5, 2016 /PRNewswire/ -- Novo Nordisk today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes.  The company also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for semaglutide.

The submission is based on the results from the SUSTAIN clinical trial program which included more than 8,000 adults with type 2 diabetes. In the SUSTAIN program, once-weekly semaglutide was studied in combination with oral-antidiabetic agents and in combination with basal insulin. Semaglutide demonstrated statistically significant and sustained blood glucose control compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo. Weight loss, a secondary endpoint, was also demonstrated in all semaglutide arms of the SUSTAIN program.  Furthermore, the cardiovascular outcomes trial, SUSTAIN 6, demonstrated a cardiovascular risk reduction compared to placebo, as add-on to standard of care in patients with high cardiovascular risk.

Across the SUSTAIN clinical trial program, the most common adverse events >5% were nausea, vomiting, diarrhea, abdominal pain and constipation.

"Achieving blood glucose control, weight loss and reducing the risk of cardiovascular events remains a significant challenge for adults with type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited with this regulatory filing as results from the SUSTAIN program show that once-weekly semaglutide has the potential to offer further improvement for adults in their treatment of type 2 diabetes."

 About semaglutide

Semaglutide is a once-weekly analog of human GLP-1 that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. Novo Nordisk intends to make semaglutide available in a prefilled delivery device based on the same technology platform as FlexTouch®.

About the SUSTAIN phase 3a clinical trial program

SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) is a global clinical trial development program for the treatment of type 2 diabetes. The study was comprised of eight Phase 3a studies of semaglutide encompassing more than 8,000 subjects around the globe.

About Novo Nordisk
Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Novo Nordisk, Inc.

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SOURCE Novo Nordisk

For further information: Media: Katrine Sperling,+45 4442 6718, krsp@novonordisk.com, Chris Clark (US), +1 609 786 8305, cpcr@novonordisk.com, Investors: Peter Hugreffe Ankersen, +45 3075 9085, phak@novonordisk.com, Melanie Raouzeos, +45 3075 3479, mrz@novonordisk.com, Hanna Ögren, +45 3079 8519, haoe@novonordisk.com, Anders Mikkelsen, +45 3079 4461, armk@novonordisk.com, Kasper Veje (US), +1 609 235 8567, kpvj@novonordisk.com
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