Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management
December 04 2020 - 7:28AM
Novo Nordisk files for US FDA regulatory approval of once-weekly
semaglutide 2.4 mg for weight management
Bagsværd, Denmark, 4 December 2020 – Novo
Nordisk today announced the submission of a new drug application
(NDA) to the US Food and Drug Administration (FDA) for subcutaneous
semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1)
analogue for chronic weight management. A priority review
voucher has been applied to the NDA, leading to an anticipated
review time of six months from the submission date, according to
standard FDA review timelines.
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 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.
“Obesity is associated with a wide range of serious
complications, yet many healthcare providers still do not have
sufficient medical options available to help people with this
chronic disease ,” said Mads Krogsgaard Thomsen, executive vice
president and chief scientific officer of Novo Nordisk. "We are
excited about the regulatory filing of semaglutide 2.4 mg in the US
and we believe once-weekly semaglutide 2.4 mg has the potential to
transform the medical management of obesity."
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.
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 74 / 2020
- PR201204_semglutide_obesity_US_submission
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