Ozempic® 2.0 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
November 12 2021 - 5:57AM
Ozempic® 2.0 mg recommended for approval for the treatment of type
2 diabetes by the European Medicines Agency
Bagsværd, Denmark, 12 November 2021 – Novo
Nordisk today announced that the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion recommending a label extension 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 positive opinion is based on the results from the SUSTAIN
FORTE trial. 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 to have a safe and well-tolerated
profile. The most common adverse events were gastrointestinal.
“The recommendation for the EU label extension of Ozempic® with
the 2.0 mg dose is an important step towards offering additional
options to people with type 2 diabetes who need treatment
intensification to achieve their individualised glycaemic targets,”
said Martin Lange, executive vice president, Development at Novo
Nordisk.
Novo Nordisk expects a final approval by the European Commission
within approximately two months, and Ozempic® 2.0 mg will be
launched in the EU in the first half of 2022. The label expansion
for semaglutide 2.0 mg is under regulatory review in the US.
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.
Novo 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 47,000 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 and YouTube.
Further information
Media: |
|
|
Mette Kruse
Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Michael Bachner
(US) |
+1 609 664
7308 |
mzyb@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
David Heiberg
Landsted |
+45 3077 6915 |
dhel@novonordisk.com |
Mark Joseph Root
(US) |
+1 848 213
3219 |
mjhr@novonordisk.com |
Company announcement No 73 / 2021
- PR211112_Semaglutide_2.0mg_EU_positive_opinion
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