PRINCETON, N.J., Feb. 16 /PRNewswire-FirstCall/ -- Novo Nordisk today announced that Victoza(R) (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.
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.
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.
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.
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.
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.
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.
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.
CONTACT: Media: Elin K. Hansen, +45-4442-3450, ekh@novonordisk.com, or in
North America: An Phan, +1-609-558-0420, anph@novonordisk.com, or
Investors: Klaus Bulow Davidsen, +45-4442-3176, klda@novonordisk.com, or
Kasper Roseeuw Poulsen, +45-4442-4471, krop@novonordisk.com, or in North
America, Hans Rommer, +1-609-919-7937, hrmm@novonordisk.com
Web site: http://www.novonordisk.com/
http://www.victoza.com/
