Novo Nordisk Makes Victoza(R) Commercially Available in the United States

PRINCETON, N.J., Feb. 16 /PRNewswire-FirstCall/ -- Novo Nordisk (NYSE: NVO) 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.  

For full prescribing information, please go to Victoza.com or call 1-877-4VICTOZA (1-877-484-2869).

Important Safety Information:

In animal studies, the medicine in Victoza caused rats and mice to develop thyroid tumors, some of which were cancerous. It is not known whether Victoza causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. MTC may lead to death. Do not use Victoza if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.  You should tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath while you are taking Victoza because these may be symptoms of thyroid cancer.

Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Certain medical conditions make you more likely to get pancreatitis. Therefore before taking Victoza, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels.

Stop taking Victoza and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. These may be symptoms of pancreatitis.

Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza.

The most common side effects with Victoza include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza, but decreases over time in most people.

Tell your healthcare provider about all the medicine you take and if you are pregnant or breastfeeding. For more information, ask your healthcare provider or pharmacist.

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. 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 (NVO). For more information, visit novonordisk-us.com.

SOURCE Novo Nordisk