Research Update

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Fri Sep 5, 2008 11:12am EDT 

  BAGSVAERD, DENMARK, Sep 05 (MARKET WIRE) -- 
FDA schedules Advisory Committee meeting for liraglutide.

    Novo Nordisk today announced that the Food and Drug Administration (FDA)
has informed the company that an FDA Advisory Committee meeting is
scheduled to be held on 2 March 2009 to discuss the New Drug Application
(NDA) for liraglutide, a once-daily human GLP-1 analogue. FDA advisory
committees are panels of independent experts who advise the FDA as they
consider regulatory decisions. The advisory committee meetings are open
to the public and are common for major pharmaceutical drugs under review.

    Novo Nordisk submitted the NDA to the FDA on 23 May 2008, meaning that an
action letter from the agency to the NDA could be expected on 23 March
2009 following a standard 10-month review period. Since the Advisory
Committee meeting is held shortly before this date, the agency has
indicated that it will most likely have to extend the date of completing
their assessment by a couple of months.

    About liraglutide

    Once-daily liraglutide is the first 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 approximately 26,300 employees in 80 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.

    Company Announcement no 56 / 2008

    Copyright Copyright Hugin AS 2008. All rights reserved.

    

Further information:

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