Research Update
30/12/2009 8:02am
UK Regulatory
TIDMNVOB
RNS Number : 8104E
Novo Nordisk A/S
30 December 2009
Company Announcement
30 December 2009
Update on timeline for formal feedback on liraglutide from the FDA
Novo Nordisk today announced that formal feedback from the United States Food
and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1
analogue, is expected within weeks. Novo Nordisk continues the constructive
dialogue with the FDA regarding the regulatory process for liraglutide.
Novo Nordisk expects to provide an update on the regulatory process
for liraglutide in connection with the announcement of the financial results for
2009 on 2 February 2010, if formal feedback is not received before then.
About liraglutide
Liraglutide is the first once-daily human Glucagon-Like Peptide-1
(GLP-1) analogue developed for the treatment of type 2 diabetes. Liraglutide
works by stimulating the release of insulin only when glucose levels become too
high and by inhibiting appetite. On 23 May 2008, Novo Nordisk submitted a New
Drug Application to the Food and Drug Administration in the US for the approval
of liraglutide for the treatment of people with type 2 diabetes. In Europe, Novo
Nordisk received marketing authorisation for liraglutide under the brand name
Victoza on 30 June, and Victoza has subsequently been launched. A New Drug
Application was also submitted for approval in Japan on 14 July 2008.
Novo Nordisk is a healthcare company and a world leader in diabetes care. In
addition, Novo Nordisk has a leading position within areas such as haemostasis
management, growth hormone therapy and hormone replacement therapy. Novo Nordisk
manufactures and markets pharmaceutical products and services that make a
significant difference to patients, the medical profession and society. With
headquarters in Denmark, Novo Nordisk employs more than 29,000 employees in 81
countries, and markets its products in 179 countries. Novo Nordisk's B shares
are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed
on the New York Stock Exchange under the symbol 'NVO'. For more information,
visit novonordisk.com
Further information:
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| Media: | Investors: |
+------------------------------------+------------------------------------+
| | |
+------------------------------------+------------------------------------+
| Mike Rulis | Mads Veggerby Lausten |
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| Tel: (+45) 3079 3573 | Tel: (+45) 4443 7919 |
+------------------------------------+------------------------------------+
| mike@novonordisk.com | mlau@novonordisk.com |
+------------------------------------+------------------------------------+
| | |
+------------------------------------+------------------------------------+
| | Kasper Roseeuw Poulsen |
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| | Tel: (+45) 3079 4471 |
+------------------------------------+------------------------------------+
| | krop@novonordisk.com |
+------------------------------------+------------------------------------+
| | |
+------------------------------------+------------------------------------+
| In North America: | In North America: |
+------------------------------------+------------------------------------+
| Sean Clements | Hans Rommer |
+------------------------------------+------------------------------------+
| Tel: (+1) 609 514 8316 | Tel: (+1) 609 216 4834 |
+------------------------------------+------------------------------------+
| secl@novonordisk.com | hrmm@novonordisk.com |
+------------------------------------+------------------------------------+
This information is provided by RNS
The company news service from the London Stock Exchange
END
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