Novo Nordisk files for EU regulatory approval of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes
December 29 2020 - 6:12AM
Novo Nordisk files for EU regulatory approval of once-weekly
semaglutide 2.0 mg for the treatment of type 2 diabetes
Bagsværd, Denmark, 29 December 2020 – Novo
Nordisk today announced the submission of a label extension
application to the European Medicines Agency (EMA) for the existing
marketing authorisation for Ozempic®, a once-weekly glucagon-like
peptide-1 (GLP-1) analogue, to introduce a new dose of
2.0 mg. Ozempic® is currently approved in the EU in 0.5
mg and 1.0 mg doses for the treatment of type 2 diabetes in
adults.
The submission is based on the results from the SUSTAIN FORTE
trial, which included 961 people with type 2 diabetes in need of
treatment intensification. In the trial, people treated with
semaglutide 2.0 mg achieved a statistically significant and
superior reduction in HbA1c at week 40 compared to semaglutide 1.0
mg. In the trial, both doses of semaglutide appeared safe and
well-tolerated. The most common adverse events were
gastrointestinal, the vast majority were mild to moderate and
diminished over time and were consistent with the GLP-1 receptor
agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal
adverse events were similar for semaglutide 2.0 mg.
“Following the announcement of the headline results in November,
we have expeditiously prepared the submission file. The submission
in the EU represents an important milestone for people living with
type 2 diabetes who have poor glycaemic control and need treatment
intensification” said Mads Krogsgaard Thomsen, executive vice
president and chief scientific officer of Novo Nordisk. "With the
2.0 mg dose, more people with type 2 diabetes will be able to
achieve treatment target”.
About the SUSTAIN clinical programme The
SUSTAIN clinical development programme for once-weekly subcutaneous
semaglutide injection currently comprises 11 phase 3 global
clinical trials, including a cardiovascular outcomes trial,
involving more than 11,000 adults with type 2 diabetes.
For more information about the SUSTAIN Forte trial, please read
the headline results 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: |
|
|
Martin Havtorn
Petersen |
+45 3075 5246 |
mhpz@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 |
- PR201229_SUSTAIN_Forte_EU_submission
Novo Nordisk (TG:NOVC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Novo Nordisk (TG:NOVC)
Historical Stock Chart
From Jul 2023 to Jul 2024