Update on timeline for formal feedback on liraglutide from the FDA (23 September 2009)
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, has been deferred until the fourth quarter of 2009. 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 the first nine months of 2009, on 29 October 2009, if formal feedback is not received before then.
This update on the timeline for formal feedback on liraglutide from the FDA does not change Novo Nordisk's expectations for the company's financial results for 2009, which were provided on 6 August in connection with the release of the financial results for the first six months of 2009.
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 (FDA) in the US for the approval of liraglutide for the treatment of people with type 2 diabetes. In Europe, Novo Nordisk received marketing authorization for liraglutide under the brand name Victoza® on 3 July 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 28,500 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.