Novo Nordisk files for EU regulatory approval of once-weekly semaglutide 2.4 mg for weight management
December 18 2020 - 2:10AM
Novo Nordisk files for EU regulatory approval of once-weekly
semaglutide 2.4 mg for weight management
Bagsværd, Denmark 18 December 2020 – Novo
Nordisk today announced the submission of a Marketing Authorisation
Application (MAA) to the European Medicines Agency (EMA) for
subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like
peptide-1 (GLP-1) analogue for weight management. The potential
indication is for the treatment of adults with obesity (BMI ≥ 30
kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one
weight-related comorbidity, as an adjunct to reduced-calorie diet
and increased physical activity.
The submission is based on the results from the STEP phase 3a
clinical trial programme, which included more than 4,500 adults
with obesity or overweight. Across the STEP programme, people with
obesity treated with once-weekly semaglutide 2.4 mg achieved a
statistically significant and superior reduction in body weight
compared to placebo. Across the trials in people without diabetes
STEP 1, 3 and 4, a weight loss of 15-18% was reported for people
treated with semaglutide 2.4 mg. Furthermore, once-weekly
semaglutide 2.4 mg appeared to have a safe and well-tolerated
profile. The most common side effects were gastrointestinal and
were transient, and mild or moderate in severity.
“We are excited about this regulatory filing following the
recent regulatory filing with the FDA in the US,” said Mads
Krogsgaard Thomsen, executive vice president and chief scientific
officer of Novo Nordisk. “It is a milestone for Novo Nordisk but
more importantly it represents a new treatment option with the
potential to transform the medical management for people living
with obesity in Europe”.
About obesity and subcutaneous semaglutide 2.4 mg for
weight management Obesity 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, heart
disease, obstructive sleep apnoea, non-alcoholic fatty liver
disease and cancer.
Once-weekly subcutaneous semaglutide 2.4 mg is being
investigated by Novo Nordisk as a potential treatment for obesity.
Semaglutide is an analogue of the human glucagon‑like peptide-1
(GLP-1) hormone. It induces weight loss by reducing hunger,
increasing feelings of fullness and thereby helping people eat less
and reduce their calorie intake.
For more information on the FDA filing for semaglutide 2.4 mg,
please read the company announcement here
About the STEP clinical programme STEP
(Semaglutide Treatment Effect in People with obesity) is a phase 3
clinical development programme with once-weekly subcutaneous
semaglutide 2.4 mg in obesity. The global phase 3a programme
consists of four trials and has enrolled approximately 4,500 adults
with overweight or obesity.
STEP 1 – a 68-week safety and efficacy trial of subcutaneous
semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or
overweight. For more information, please read the company
announcement here
STEP 2 – a 68-week safety and efficacy trial of subcutaneous
semaglutide 2.4 mg versus placebo and once-weekly subcutaneous
semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either
obesity or overweight. For more information, please read the
company announcement here
STEP 3 – a 68-week safety and efficacy trial of subcutaneous
semaglutide 2.4 mg versus placebo in combination with intensive
behavioural treatment in 611 adults with obesity or overweight. For
more information, please read the company announcement here
STEP 4 – a 68-week safety and efficacy trial of subcutaneous
semaglutide 2.4 mg versus placebo in 803 adults with obesity or
overweight who have reached the target dose of 2.4 mg after a
20-week run-in. For more information, please read the company
announcement here
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
44,000 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 |
Ken Inchausti
(US) |
+1 609 240
9429 |
kiau@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Valdemar Borum
Svarrer |
+45 3079 0301 |
jvls@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
Mark Joseph
Root |
+45 3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due
Berg (US) |
+1 609 235
2989 |
krdb@novonordisk.com |
Company announcement No 78 / 2020
- PR201218_semaglutide_obesity_EMA_submission
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