Novo Nordisk files for regulatory approval in the US of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes
January 20 2021 - 10:07AM
Novo Nordisk files for regulatory approval in the US of once-weekly
semaglutide 2.0 mg for the treatment of type 2 diabetes
Bagsværd, Denmark, 20 January 2021 – Novo
Nordisk today announced the submission of a label expansion
application to the US Food and Drug Administration (FDA) 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 US in 0.5 mg
and 1.0 mg doses for the treatment of type 2 diabetes in adults and
to reduce the risk of major adverse cardiovascular events in adults
with type 2 diabetes mellitus and established cardiovascular
disease. The submission follows the application on 29 December 2020
for label extension to the European Medicines Agency (EMA).
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 compared to semaglutide 1.0 mg. In the
trial, both doses of semaglutide appeared to have safe and
well-tolerated profiles. 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.
“We are excited about the regulatory submission of semaglutide
2.0 mg to the FDA,” said Mads Krogsgaard Thomsen, executive vice
president and chief scientific officer of Novo Nordisk. “In the
SUSTAIN programme most people achieved the treatment target of
HbA1c levels below 7%. However, some patients need treatment
intensification and 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: |
|
|
Anne Margrethe
Hauge |
+45 4442 3450 |
amhg@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 |
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 3 / 2021
- PR210120_SUSTAIN_Forte_FDA 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