Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
12 November 2021 - 10:13PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
November 11, 2021
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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)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F [X]
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Form 40-F [ ]
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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-________
Wegovy™ recommended
for approval for the treatment of obesity by the European regulatory authorities
Bagsværd,
Denmark, 11 November 2021 – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Wegovy™ for chronic weight
management in adults with obesity.
Wegovy™ is a once-weekly semaglutide
2.4 mg injection for chronic weight management in adults living with obesity (initial
BMI≥30 kg/m2) or overweight (initial
BMI≥27 kg/m2) with at least one weight-related comorbidity such as high blood pressure,
heart disease or type 2 diabetes.
The positive CHMP
opinion is based on results from the STEP phase 3a clinical trial programme. Across the trials in people with obesity or overweight
without type 2 diabetes, an average weight loss of 17-18%1 sustained over 68 weeks was
reported for those treated with Wegovy™. Wegovy™ demonstrated a safe and well-tolerated profile across the programme, with
the most common adverse events being gastrointestinal.
“With the unprecedented and sustained weight loss
for an anti-obesity medication, Wegovy™ has the potential to transform obesity management and help millions of people living with
obesity,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “We are looking forward to driving
change for people with obesity by introducing Wegovy™ in Europe next year.”
Novo Nordisk expects to receive final marketing authorisation
from the European Commission in approximately two months.
Wegovy™ was launched in the US in June 2021 following
approval by the U.S. Food and Drug Administration (FDA). In September 2021, Wegovy™ was approved by the UK Medicines and Health
products Regulations Agency (MHRA). Novo Nordisk expects to launch Wegovy™ in Europe in the second half of 2022.
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About obesity
Obesity is a chronic disease that requires long-term
management. It is associated with many serious health complications and decreased life expectancy. Obesity-related complications are numerous
and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and certain types of cancer. The
current COVID-19 pandemic has highlighted that obesity also increases the risk of severe illness and hospitalisation due to COVID-19.
The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare systems. Approximately 650 million adults are estimated to live with obesity
worldwide and specifically 53% of the adults living in the EU are considered
to be living with overweight.
About Wegovy™ (semaglutide
2.4 mg) and STEP
Semaglutide 2.4 mg is an analogue of the human glucagon-like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feeling of fullness and thereby helping people eat less and reduce their calorie intake.
Once-weekly semaglutide 2.4 mg injection is approved for the treatment of adults with obesity or overweight in the US and
UK, as an adjunct to diet and exercise.
The approval is based on the results from the STEP
(Semaglutide Treatment Effect in People with obesity) phase 3 clinical development programme. The global clinical phase
3a programme consists of four trials and enrolled approximately 4,500 adults with overweight or obesity.
About Novo Nordisk
Novo Nordisk is a leading global healthcare
company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic
diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access
to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 47,000 people in 80 countries and
markets its products in around 170 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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Further
information
Media:
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Mette Kruse Danielsen
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+45 3079 3883
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mkd@novonordisk.com
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Michael Bachner (US)
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+1 609 664 7308
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mzyb@novonordisk.com
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Investors:
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Daniel Muusmann Bohsen
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+45 3075 2175
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dabo@novonordisk.com
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Valdemar Borum Svarrer
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+45 3079 0301
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Ann Søndermølle Rendbæk
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+45 3075 2253
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arnd@novonordisk.com
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David Heiberg Landsted
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+45 3077 6915
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dhel@novonordisk.com
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Mark Joseph Root (US)
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+1 848 213 3219
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mjhr@novonordisk.com
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___________________________
1 Based on the trial
product estimand (secondary statistical approach): treatment effect if all people adhered to treatment and did not initiate other anti-obesity
therapies. When using a treatment policy estimand, 15-17% weight loss was reported.
Novo Nordisk A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no:
24 25 67 90
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Company announcement No 72
/ 2021
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: November 12, 2021
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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