Wegovy™ recommended for approval for the treatment of obesity by the European regulatory authorities
November 11 2021 - 10:53AM
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.
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
STEPSemaglutide 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 NordiskNovo 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
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 |
Valdemar Borum
Svarrer |
+45 3079 0301 |
|
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 72 / 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.
- PR211111_ Wegovy_EU_positive_opinion
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