Novo Nordisk announced today that the US Food and Drug Administration (FDA) has granted marketing authorisation for Levemir®, the company's long-acting insulin analogue for the treatment of diabetes. With the US approval of Levemir®, Novo Nordisk is the only company in the US with a complete range of insulin analogues, encompassing rapid-acting NovoLog®, premixed NovoLog® Mix 70/30 and now also the long-acting analogue Levemir®.
"The US approval of Levemir® is an important event for Novo Nordisk in the US as it completes our portfolio of insulin analogues and thereby paves the way for continued expansion of our US diabetes care franchise," says Kåre Schultz, executive vice president and chief operating officer.
In addition to the US approval, Levemir® has already been approved for use in 37 countries, including the countries in the European Union. The product has been introduced in 11 European markets, with additional launches expected during the second half of 2005.
Levemir® is a soluble, long-acting basal human insulin analogue with a relatively flat action profile and prolonged duration of action of up to 24 hours. Levemir® is indicated for once or twice-daily subcutaneous administration in the treatment of adult patients with diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia. Levemir® can be used as the basal component of basal-bolus therapy in type 1 and type 2 diabetes and as add-on therapy in people with type 2 diabetes who are inadequately controlled on oral antidiabetic agents. The file on use in paediatrics is under review with the FDA and a decision is expected before the end of 2005.
Novo Nordisk expects to introduce Levemir® in the US market within the next 12 months. The approval of Levemir® does not change Novo Nordisk's expectations for the financial results for 2005.
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. 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 21,000 full-time employees in 78 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.
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Stock Exchange Announcement no 18 / 2005