Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec
July 10 2024 - 5:45PM
UK Regulatory
Novo Nordisk receives Complete Response Letter in the US for
once-weekly basal insulin icodec
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk
today announced that the US Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) covering the Biologics
License Application for once-weekly basal insulin icodec for the
treatment of diabetes mellitus.
In the letter, the FDA has requests related to the manufacturing
process and the type 1 diabetes indication before the review of the
application can be completed. Novo Nordisk is evaluating the
content of the CRL and will work closely with the FDA to fulfil the
requests. Novo Nordisk does not expect to be able to fulfil the
requests during 2024.
‘We believe in the potential of once-weekly basal insulin icodec
for those living with diabetes who require basal insulin therapy,”
said Martin Lange, executive vice president for Development at Novo
Nordisk. “We will work closely with the FDA to identify the next
steps needed to complete the review so we can provide this novel
treatment option to adults living with diabetes’’.
Novo Nordisk submitted the application for insulin icodec to the
FDA in April 2023. In May 2024, an FDA Endocrinologic and Metabolic
Drugs Advisory Committee meeting was convened with a panel of
independent scientific experts to discuss the benefit-risk of
once-weekly basal insulin icodec in type 1 diabetes. The panel
determined that the data available were not sufficient to conclude
on a positive benefit-risk in type 1 diabetes. The Advisory
Committee did not discuss the use of once-weekly insulin icodec in
type 2 diabetes.
Insulin icodec is approved under the brand name
Awiqli® in the EU, Canada, Australia, Japan and
Switzerland for the treatment of both type 1 and type 2 diabetes
and in China for the treatment of type 2 diabetes.
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 66,000 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,
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Contacts for further information
Media: |
|
Ambre
James-Brown
+45 3079 9289
abmo@novonordisk.com
|
Liz
Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
|
Investors: |
|
Jacob
Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com
|
David
Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com
|
Sina
Meyer
+45 3079 6656 azey@novonordisk.com
|
Frederik
Taylor Pitter
+45 3075 8259 fptr@novonordisk.com
|
Ida
Melvold Gjøsund
+45 3077 5649 idmg@novonordisk.com
|
Mark
Joseph Root (US)
+1 848 213 3219
mjhr@novonordisk.com
|
Company announcement No 52 / 2024
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