Novo Nordisk A/S: Research Update
BAGSVAERD, DENMARK--(Marketwire - March 31, 2009) - 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
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.