NVO Novo Nordisk

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

February 28, 2017

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NOVO NORDISK A/S

  (Exact name of Registrant as specified in its charter)

Novo Allé 

DK- 2880, Bagsvaerd 

Denmark

(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________

Novo Nordisk files for regulatory approval of once- weekly semaglutide for the treatment of type 2 diabetes in Japan

Bagsværd, Denmark, 28 February 2017 – Novo Nordisk today announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes. The Japanese filing follows the recent once-weekly semaglutide regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic.

The Japanese submission is based on results from the SUSTAIN clinical trial programme. The SUSTAIN programme involved more than 8,000 adults with type 2 diabetes, with approximately 1,200 participants from Japan. Trial participants were treated with once- weekly semaglutide as monotherapy, or with oral-antidiabetic (OAD) agents or in combination with OADs and basal insulin. Across the SUSTAIN programme, once-weekly semaglutide demonstrated statistically significant reductions in HbA 1c as well as statistically significant reductions in mean body weight compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo.

Across the SUSTAIN clinical trial programme, once-weekly semaglutide had a well- tolerated safety profile, with the most common adverse event being nausea.

“We are very excited about having filed the regulatory application for once-weekly semaglutide in Japan,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “Based on the results from the global SUSTAIN clinical trial programme, we believe that once-weekly semaglutide has the potential to improve the treatment for many type 2 patients in Japan.”

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About semaglutide

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

About the SUSTAIN phase 3a clinical trial programme

SUSTAIN is a global clinical trial programme for once-weekly semaglutide that comprises seven phase 3a clinical trials and a cardiovascular outcomes trial, involving more than 8,000 adults with type 2 diabetes.

The SUSTAIN Japan Monotherapy trial showed that, from a mean baseline HbA 1c of 8.1%, 308 adults with type 2 diabetes treated once-weekly with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater HbA 1c reductions of 1.9% and 2.2%, respectively, vs 0.7% with 100 mg sitagliptin at 30 weeks, both as monotherapy. Additionally, from a mean baseline body weight of 69.3 kg, adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater weight loss of 2.2 kg and 3.9 kg, respectively, compared with no change in body weight with sitagliptin.

The SUSTAIN Japan OAD combination trial showed that, from a mean baseline HbA 1c of 8.1%, 600 adults with type 2 diabetes treated once-weekly with 0.5 mg or 1.0 mg semaglutide, as monotherapy or in combination with one OAD treatment, achieved statistically significantly greater HbA 1c reductions of 1.7% and 2.0%, respectively, vs 0.7% with OAD therapy at 56 weeks. In addition, from a mean baseline weight of 71.5 kg, adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significant weight loss of 1.4 kg and 3.2 kg, respectively, compared with a weight gain of 0.4 kg with OAD therapy.

The SUSTAIN 1 trial showed that, from a mean baseline HbA 1c of 8.1%, 388 adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater HbA 1c reductions of 1.5% and 1.6%, respectively, vs <0.1% with placebo. The trial also demonstrated that adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater reductions from baseline in mean body weight of 3.7 kg and 4.5 kg, respectively, vs 1.0 kg with placebo.

The SUSTAIN 2 trial showed that from a mean baseline HbA 1c of 8.1%, 1,231 adults with type 2 diabetes treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater HbA 1c reductions of 1.3% and 1.6%, respectively, vs 0.5% with 100 mg sitagliptin at 56 weeks (both p<0.0001), as add-on to metformin and/or thiazolidinediones. In addition, from a mean baseline body weight of 89.5 kg, adults with type 2 diabetes achieved statistically significantly greater reductions in mean body weight when treated with 0.5 mg or 1.0 mg semaglutide vs sitagliptin (4.3 kg and 6.1 kg vs 1.9 kg; both p<0.0001).

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The SUSTAIN 3 trial showed that 813 adults with type 2 diabetes and a mean baseline HbA 1c of 8.3% achieved a statistically significantly greater HbA 1c reduction of 1.5% when treated with 1.0 mg semaglutide vs 0.9% with 2.0 mg exenatide extended-release (ER) (p<0.0001), as add-on to one or two oral antidiabetics (metformin, sulfonylurea or thiazolidinediones). Furthermore, from a mean baseline body weight of 95.8 kg, adults with type 2 diabetes achieved a statistically significantly greater reduction in mean body weight when treated with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (5.6 kg vs 1.9 kg; p<0.0001).

The SUSTAIN 4 trial showed that from a mean baseline HbA 1c of 8.2%, 1,089 adults with type 2 diabetes receiving metformin with or without sulfonylurea, achieved statistically significantly greater improvements in HbA 1c reductions of 1.2% and 1.6% when treated with 0.5 mg or 1.0 mg semaglutide, respectively, vs a 0.8% reduction with insulin glargine U100 (p<0.0001 for both). End of trial mean dose of insulin glargine U100 was 29 IU/day. Additionally, from a mean baseline body weight of 93.4 kg, adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater reductions in mean body weight of 3.5 kg and 5.2 kg compared to an increase of 1.2 kg with insulin glargine U100 (p<0.0001 for both).

The SUSTAIN 5 trial showed that, from a mean baseline HbA 1c of 8.4%, 397 adults treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater HbA 1c reductions of 1.4% and 1.8%, respectively, vs 0.1% reduction with placebo, when added on to basal insulin with or without metformin. In addition, adults with type 2 diabetes treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significantly greater weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a mean baseline body weight of 91.7 kg.

In the SUSTAIN 6 trial, once-weekly semaglutide statistically significantly reduced the risk of major adverse cardiovascular events (MACE), defined as the composite endpoint of time to first occurrence of either cardiovascular (CV) death, nonfatal myocardial infarction or non-fatal stroke, by 26% vs placebo, when added to standard of care in 3,297 adults with type 2 diabetes at high CV risk.

About Novo Nordisk

Novo Nordisk is a global healthcare 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: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

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