Awiqli® (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities
21 März 2024 - 4:55PM
Awiqli® (once-weekly basal insulin icodec) recommended for approval
for the treatment of diabetes by the European regulatory
authorities
Bagsværd, Denmark, 21 March 2024 – Novo Nordisk
today announced that the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion, recommending marketing authorisation for Awiqli® (the
brand name for once-weekly basal insulin icodec) for treatment of
diabetes in adults.
The positive CHMP opinion is based on results from the ONWARDS
phase 3a clinical trial programme. Once-weekly basal insulin icodec
achieved superior blood sugar reduction1 (measured by a change in
HbA1c) and superior Time in Range2 (time spent within recommended
blood sugar range), compared with daily basal insulin in people
with type 2 diabetes. In people with type 2 diabetes who have not
previously been treated with insulin, overall observed rates of
clinically significant or severe hypoglycaemia3 were below one
event per patient-year of exposure with both once-weekly basal
insulin icodec and comparators. In people with type 1 diabetes,
once-weekly basal insulin icodec demonstrated non-inferiority in
reducing HbA1c with a statistically significant higher estimated
rate of severe or clinically significant hypoglycaemia compared
with insulin degludec4. Across the programme, once-weekly basal
insulin icodec appeared to have a safe and well-tolerated
profile.
“We believe that by reducing the number of basal insulin
injections from seven to one per week, Awiqli® has the potential to
have a significant impact and improve treatment for people living
with diabetes,” said Martin Holst Lange, executive vice president
for Development at Novo Nordisk. “We are committed to driving
innovation in diabetes treatment, and Awiqli® has the potential to
become the insulin of choice for people with type 2 diabetes
initiating insulin treatment.”
Novo Nordisk expects to receive final marketing authorisation
from the European Commission within approximately two months.
About Awiqli® (once-weekly basal
insulin icodec) and the ONWARDS programmeAwiqli® is a
once-weekly basal insulin analogue designed to cover the basal
insulin requirements for a full week with a single subcutaneous
injection.
The ONWARDS clinical development programme comprised six phase
3a global clinical trials, which investigated the efficacy and
safety of once-weekly basal insulin icodec, involving more than
4,000 adults with type 1 or type 2 diabetes, including a trial with
real-world elements.
Novo Nordisk is a leading global healthcare company, founded in
1923 and headquartered in Denmark. Our purpose is to drive change
to defeat serious chronic diseases, built upon our heritage in
diabetes. We do so by pioneering scientific breakthroughs,
expanding access to our medicines, and working to prevent and
ultimately cure disease. Novo Nordisk employs about 63,400 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, Instagram, X,
LinkedIn and YouTube.
Contacts for further information
Media: |
|
Ambre
James-Brown +45 3079 9289abmo@novonordisk.com |
Liz
Skrbkova (US)+1 609 917 0632 lzsk@novonordisk.com |
Investors: |
|
Daniel
Muusmann Bohsen+45 3075 2175 dabo@novonordisk.com |
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
- vs insulin glargine U100 and insulin
degludec in ONWARDS 1,2 and 3
- vs insulin glargine U100 in ONWARDS
1
- Clinically significant hypoglycaemia
defined as blood glucose below 3 mmol/L; severe hypoglycaemia
defined as hypoglycaemia associated with severe cognitive
impairment requiring external assistance for recovery
- vs insulin degludec in ONWARDS
6
Company announcement 25 / 2024
- PR240320-Icodec-positive-opinion-EU
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