Wegovy™ (semaglutide 2.4 mg), the first and only once-weekly GLP-1 therapy for weight management, approved in the US
June 04 2021 - 2:10PM
Wegovy™ (semaglutide 2.4 mg), the first and only once-weekly GLP-1
therapy for weight management, approved in the US
Bagsværd,
Denmark,
4 June 2021 –
Novo Nordisk today announced that the US Food and Drug
Administration (FDA) has approved Wegovy™ (the brand name for
once-weekly semaglutide 2.4 mg injection in the US) for chronic
weight management. Wegovy™ is indicated as an adjunct to diet and
exercise for chronic weight management in adults with obesity
(initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at
least one weight-related comorbidity.
Wegovy™ is the first and only once-weekly glucagon-like
peptide-1 (GLP-1) receptor agonist therapy approved for
weight management for people living with obesity. The approval is
based on the results from the STEP phase 3a clinical trial
programme. Across the trials in people without type 2 diabetes, an
average weight loss of 17-18%1 sustained over 68 weeks was reported
for people with obesity treated with Wegovy™. Wegovy™ demonstrated
a safe and well-tolerated profile across the programme, with the
most common adverse events being gastrointestinal.
“The approval of Wegovy™ in the US brings great promise to
people with obesity. Despite the best efforts to lose weight, many
people with obesity struggle to achieve and maintain weight loss
due to physiological responses that favour weight regain,” said
Martin Holst Lange, executive vice president, Development at Novo
Nordisk. “The unprecedented weight loss for an anti-obesity
medication marks a new era in the treatment of obesity, and we now
look forward to making Wegovy™ available to people living with
obesity in the US”.
Novo Nordisk expects to launch WegovyTM in the United States
later in June 2021.
Conference callOn 7 June at 8.30 CEST,
corresponding to 2.30 am EDT, 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 obesityObesity 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 for 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.
About Wegovy™
(semaglutide
2.4 mg) and
STEPSemaglutide 2.4 mg is a GLP-1 receptor agonist, with
94% similarity to naturally occurring human 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, in addition to diet and exercise.
Semaglutide 2.4 mg for weight management is currently under
regulatory review in the EU and other countries. The submissions
are 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 45,800 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.
Further information
Media: |
|
|
Mette Kruse
Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Michael Bachner
(US) |
+1 609 664
7308 |
mzyb@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
David Heiberg
Landsted |
+45
3077 6915 |
dhel@novonordisk.com |
Mark Joseph
Root (US) |
+1 848 213
3219 |
mjhr@novonordisk.com |
Company announcement No 38 / 2021
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.
- PR200604_Sema_obesity_approval
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