FDA Approves Levemir(R) (insulin detemir [rDNA Origin] Injection) - a New, Long-Acting Insulin Treatment for Diabetes

PRINCETON, N.J., June 17 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir(R) (insulin detemir [rDNA origin] injection) for the treatment of diabetes mellitus (type 1 and type 2). Levemir is a novel, long- acting form of insulin that provides up to a 24-hour duration of action and has been shown to cause little weight change.(1)

(Logo: http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO )

"Experts agree there is a significant need for consistent good control of patients' glucose levels, which is associated with a reduced risk of diabetes complications," said Peter Aurup, M.D., Vice President of the Clinical Development, Medical, and Regulatory Affairs department. "The results seen to date with Levemir affirm the value that the product will provide to patients who struggle to manage their diabetes."

Additionally, a New Drug Application (NDA) for Levemir for pediatric indication is currently under review by the FDA.

The safety and efficacy of Levemir given once or twice daily was compared to NPH human insulin or insulin glargine in controlled clinical studies involving a total of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In one study, a treat-to-target efficacy study of 475 patients using Levemir or NPH insulins, 70 percent of those treated with Levemir achieved an A1C of approximately 6.6 percent, which meets the target level recommended by the American Diabetes Association. There was no significant difference between the two treatment arms. In other studies, Levemir achieved a level of glycemic control similar to that provided by other basal insulins, as measured by A1C.(2)

About Levemir

Levemir is indicated for once- or twice-daily subcutaneous injection, depending on blood glucose control and insulin requirements throughout the day. Levemir provides a relatively flat action profile. Levemir can be used in monotherapy, added to oral anti-diabetic agents, or used in combination with a rapid-acting insulin. Levemir has already been approved for use in 37 countries worldwide, including countries throughout Europe. As of January 2005, approximately 88,075 patients have been treated with Levemir.

Hypoglycemia is the most common adverse effect of insulin therapy, including Levemir. Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash. Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients.

About Diabetes

Diabetes, a disease in which the body does not produce or properly use insulin, affects 18.2 million people in the U.S., or 6.3 percent of the population, of which 5.2 million people (or nearly one-third) are unaware that they have the condition.(3) Diabetes is the fifth leading cause of death by disease in the U.S and costs an estimated $132 billion per year in medical expenses and lost productivity.(4) According to the World Health Organization, the total number of people with diabetes worldwide is projected to rise from 171 million in 2000 to 366 million in 2030.(5)

Type 1 diabetes results from the body's failure to produce insulin, the hormone that "unlocks" the cells of the body, allowing glucose to enter and fuel them. It is estimated that 5-10 percent of Americans who are diagnosed with diabetes have type 1 diabetes. Type 2 diabetes results from insulin resistance (a condition in which the body fails to properly use insulin), combined with relative insulin deficiency. Most Americans who are diagnosed with diabetes have type 2 diabetes. Research studies in the United States and abroad have found that improved glycemic control benefits people with either type 1 or type 2 diabetes.(6)

Full prescribing information for Levemir is available by contacting Novo Nordisk Inc. or visiting http://www.novonordisk-us.com/.

Levemir is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. With the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems, Novo Nordisk is a world leader in diabetes care. In the United States, Novo Nordisk's ambition is to change the course of diabetes for good. Working as a catalyst to improve diabetes prevention and treatment, the company strives to be the preferred partner for employees, patients, healthcare providers, and others in the healthcare system who share its vision to defeat diabetes. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. 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 global information, visit http://www.novonordisk.com/; for United States information, visit http://www.novonordisk-us.com/.

(1) Levemir(R) (insulin detemir). Product information. Novo Nordisk Inc., Princeton, NJ. May, 2005. (2) Levemir(R) (insulin detemir). Product information. Novo Nordisk Inc., Princeton, NJ. May, 2005. (3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. Accessed June 10, 2005. (4) American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2002, Diabetes Care. Available at http://care.diabetesjournals.org/cgi/content/full/26/3/917. Accessed June 10, 2005. (5) World Health Organization. Global Prevalence of Diabetes: Estimates for the year 2000 and projections for 2030. Available at http://www.who.int/diabetes/facts/en/diabcare0504.pdf. Accessed June 10, 2005. (6) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. Accessed June 10, 2005.