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
(http://www.novonordisk.com), Facebook (http://www.facebook.com/novonordisk),
Instagram (https://www.instagram.com/novonordisk), X
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk) and YouTube
(http://www.Youtube.com/novonordisk).
Contacts for further information
Media:

 Ambre James-Brown                      Liz Skrbkova (US)
 +45 3079 9289                          +1 609 917 0632
 abmo@novonordisk.com                   lzsk@novonordisk.com
 (mailto:abmo@novonordisk.com)          (mailto:lzsk@novonordisk.com)

Investors:

 Jacob Martin Wiborg Rode               David Heiberg Landsted
 +45 3075 5956                          +45 3077 6915
 jrde@novonordisk.com                   dhel@novonordisk.com
 (mailto:jrde@novonordisk.com)          (mailto:dhel@novonordisk.com)
 Sina Meyer                             Frederik Taylor Pitter
 +45 3079 6656 azey@novonordisk.com     +45 3075 8259 fptr@novonordisk.com
 (mailto:azey@novonordisk.com)          (mailto:fptr@novonordisk.com)
 Ida Melvold Gjøsund                    Mark Joseph Root (US)
 +45 3077 5649 idmg@novonordisk.com     +1 848 213 3219
 (mailto:idmg@novonordisk.com)          mjhr@novonordisk.com
                                        (mailto:mjhr@novonordisk.com)

Company announcement No 52 / 2024
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