Wegovy® approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease
08 März 2024 - 7:42PM
Wegovy® approved in the US for cardiovascular risk reduction in
people with overweight or obesity and established cardiovascular
disease
Bagsværd, Denmark, 8 March 2024 – Novo Nordisk
today announced that the US Food and Drug Administration (FDA) has
approved a label expansion for Wegovy® based on a supplemental New
Drug Application (sNDA) for the indication of reducing risks of
major adverse cardiovascular events (MACE) including cardiovascular
death, non-fatal heart attack (myocardial infarction) or non-fatal
stroke in adults with either overweight or obesity and established
cardiovascular disease (CVD).
The approval is based on the SELECT cardiovascular outcomes
trial, which demonstrated that Wegovy® statistically significantly
reduced the risk of MACE by 20% compared to placebo when added to
standard of care. The exact mechanism of cardiovascular risk
reduction has not been established.
The findings from SELECT also showed that over a period of up to
five years, risk reductions in MACE were achieved regardless of
baseline age, sex, race, ethnicity, body mass index (BMI) and level
of renal function impairment. In addition, the label is updated to
include data from SELECT showing a risk reduction in cardiovascular
death by 15% and a risk reduction of death from any cause by 19%,
both compared to placebo1. Further, additional clinical data from
SELECT are included in the label.
"We are very pleased that Wegovy® is now approved in the US as
the first therapy to help people manage their weight and reduce
cardiovascular risks," said Martin Holst Lange, executive vice
president and head of Development at Novo Nordisk. “This approval
is an important milestone for people living with obesity and
cardiovascular disease, as the SELECT data demonstrated that
Wegovy® has the potential to prolong lives by addressing some of
the leading causes of preventable deaths by reducing the risks of
cardiovascular events.”
Novo Nordisk has also filed for a label expansion in the EU, and
a decision is expected in 2024.
About obesity and cardiovascular diseaseObesity
is a chronic disease that requires long-term management. It is
associated with many serious health consequences and decreased life
expectancy. Obesity-related complications are numerous and include
type 2 diabetes, chronic kidney disease, non-alcoholic fatty liver
disease, cancer and an increased risk of CVD, including heart
attack and stroke, high levels of blood sugar, cholesterol, blood
pressure and inflammation.
About the SELECT trial SELECT was a randomised,
double-blind, parallel-group, placebo-controlled trial designed to
evaluate the efficacy of semaglutide 2.4 mg versus placebo as an
adjunct to standard of care for prevention of MACE in people with
established CVD with overweight or obesity with no prior history of
diabetes over a period of five years. People included in the trial
were aged ≥45 years with a BMI ≥27 kg/m2.
The primary objective of the SELECT trial was to demonstrate the
superiority of semaglutide 2.4 mg compared to placebo with respect
to reducing the incidence of three-point MACE consisting of
cardiovascular death, non-fatal heart attack (myocardial
infarction) or non-fatal stroke. Key secondary objectives were to
compare the effects of semaglutide 2.4 mg to placebo regarding
mortality, heart failure, cardiovascular risk factors, including
glucose metabolism, body weight and kidney function. The trial
enrolled 17,604 adults and was conducted in 41 countries at more
than 800 investigator sites. SELECT was initiated in 2018.
The SELECT data were presented at the American Heart Association
(AHA) annual meeting in November 2023 and published in the New
England Journal of Medicine (NEJM).
About Wegovy®
(semaglutide 2.4 mg) Following the US label
update, Wegovy® is now indicated in combination with a reduced
calorie diet and increased physical activity to reduce the risk of
MACE in adults with established cardiovascular disease and either
obesity or overweight, as well as to reduce excess body weight and
maintain weight reduction long term in adults and paediatric
patients aged 12 years and older with obesity and in adults with
overweight in the presence of at least one weight-related comorbid
condition.
Wegovy® has also been launched in Denmark, Norway, Germany, the
UK, Iceland, Switzerland, UAE and Japan. Here Wegovy® is indicated
as an adjunct to a reduced calorie diet and increased physical
activity for chronic weight management in adults with a BMI of 30
kg/m2 or greater (obesity), adults with a BMI of 27 kg/m2 or
greater (overweight) in the presence of at least one weight-related
comorbid condition, and in Denmark, Norway, Germany, UK, Iceland,
and UAE, also for paediatric patients aged 12 years and older with
an initial BMI at the 95th percentile or greater for age and gender
(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 serious chronic diseases, built upon our heritage in
diabetes. We do so by pioneering scientific breakthroughs,
expanding access to our medicines, and working to prevent and
ultimately cure disease. Novo Nordisk employs about 63,400 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, Instagram, X,
LinkedIn and YouTube.
Contact for further information:
Media: |
|
Ambre
James-Brown +45 3079 9289abmo@novonordisk.com |
Liz
Skrbkova (US)+1 609 917 0632lzsk@novonordisk.com |
Investors: |
|
Daniel
Muusmann Bohsen+45 3075 2175 dabo@novonordisk.com |
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
Company announcement No 21 / 2024
1 Cardiovascular death superiority not confirmed (hazard ratio:
0.85 (0.71;1.01)). Death by any cause not statistically significant
based on the prespecified testing hierarchy (hazard ratio: 0.81
(0.71; 0.93)).
- PR240308-SELECT-US-label-update
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