Liraglutide briefing documents now available for the FDA Advisory
Committee meeting on 2 April
Novo Nordisk announced today that the United States Food and Drug
Administration (FDA) has made liraglutide briefing documents publicly
available on its website (www.fda.gov) ahead of the Endocrinologic
and Metabolic Drugs Advisory Committee public meeting on 2 April
2009. This is a common procedure in connection with advisory
committee meetings.
The briefing documents from Novo Nordisk and the FDA provide an
overview of the non-clinical and clinical data for liraglutide in the
treatment of type 2 diabetes and will form the basis for the Advisory
Committee's discussion. The Novo Nordisk briefing document contains
data from 40 clinical studies involving more than 6,800 people with
type 2 diabetes of which more than 4,600 were treated with
liraglutide.
The Advisory Committee is expected to make recommendations to the FDA
on questions related to the approval of liraglutide for the treatment
of type 2 diabetes based on the overall benefit:risk profile of
liraglutide.
FDA advisory committees are panels of independent experts who advise
the FDA as they consider regulatory decisions.
Conference call
On 3 April at 8 am CET, corresponding to 2 am EDT, a conference call
for investors will be held. Investors will be able to listen in via a
link on the investor section of novonordisk.com.
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 as well as a marketing authorisation
application to the European Medicines Agency in Europe, for the
approval of liraglutide for the treatment of people with type 2
diabetes. A New Drug Application was also submitted for approval in
Japan on 15 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 27,000
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.
Contacts for further information:
Media: Investors:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 4442 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com
In North America: In North America:
An Phan Hans Rommer
Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937
anph@novonordisk.com hrmm@novonordisk.com
Company Announcement no 18 / 2009
