Victoza Now Commercially Available in the United States

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 US 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.

Source: Novo Nordisk