DiabetesSource

Novo Nordisk today announced that Victoza® (liraglutide [rDNA origin] injection) is now available in the United States. Victoza is the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. It is indicated in the U.S. as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. Victoza can be used alone (monotherapy) as well as in combination with other oral anti-diabetic medications as demonstrated by clinical studies highlighted in the prescribing information.

"Novo Nordisk is proud to offer a new treatment option for type 2 diabetes patients who have been unsuccessful at controlling their blood sugar," said Jerzy Gruhn, president of Novo Nordisk Inc. "Victoza provides a once-a-day treatment that not only lowers blood sugar, but helps to reduce weight. We believe many people with type 2 diabetes will benefit from Victoza and we are pleased to add this significant new treatment to our diabetes portfolio."

Victoza is not insulin. It is not known if Victoza is safe and effective when used with insulin. Victoza is not for people with type 1 diabetes or people with diabetic ketoacidosis. Victoza is not recommended for use in children.

"Victoza has been extensively studied both as monotherapy, as well as in combination with current anti-diabetic medications, and has consistently demonstrated glucose control in both scenarios," said Alan J. Garber, MD, PhD, FACE, Professor of Medicine, Biochemistry and Molecular Biology, and Cellular Biology Department of Medicine Baylor College of Medicine Houston, Texas. "Victoza will provide patients with an effective therapy for type 2 diabetes that not only lowers blood sugar, but shows weight loss and low risk of hypoglycemia."

In January, Victoza received a rapid approval by the Japanese regulatory authorities. The European Medicines Agency (EMA) granted marketing authorization for Victoza on June 30, 2009 for all 27 European Union member states. In addition, as of January 2010, approval has also been granted by the regulatory authorities in Norway, Mexico, Iceland and Switzerland. Victoza has already been commercially launched in the UK, Germany, Denmark, Ireland, the Netherlands, Greece, Sweden and Norway and will be available in other markets throughout 2010. A New Drug Application was also submitted for approval in China in August 2009. A regulatory decision is pending.

About Victoza
Victoza is the first and only human GLP-1 analog with 97% homology to native GLP-1. Like native GLP-1, Victoza works by stimulating the beta cells to release insulin only when blood glucose levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia. The mechanism of blood glucose lowering also involves a delay in gastric emptying.

Victoza was evaluated in The Liraglutide Effect and Action in Diabetes (LEAD) phase III trials, the most comprehensive clinical development program conducted to date by Novo Nordisk Inc. in type 2 diabetes. In clinical studies including use as monotherapy and in combination with standard diabetes treatments, Victoza produced significant reductions in A1C and also was associated with weight loss.

Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 29,000 employees in 81 countries, and markets its products in 179 countries.