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Novo Nordisk's Victoza(R) Receives FDA Approval for Adults With Type 2 Diabetes
Date:1/25/2010

n-org">Baylor College of Medicine Houston, Texas.  "The approval of Victoza provides patients a once daily treatment that not only lowers blood sugar, but unlike many other diabetes therapies, does not promote weight gain and is associated with weight loss in the majority of patients. Additionally, it offers patients an attractive new treatment option that has consistently performed well when compared to other currently available treatments."

The American Diabetes Association and European Association for the Study of Diabetes as well as the American Association of Clinical Endocrinologists and the American College of Endocrinology recently updated their treatment algorithms for type 2 diabetes. The algorithms recommend GLP-1 agonists like Victoza as a viable treatment option when blood sugar goals are not met or maintained with lifestyle adjustments and metformin.

Novo Nordisk expects to introduce Victoza in the U.S. market in 4 – 6 weeks.  In addition to the U.S. approval, Victoza has been approved by the European Medicines Agency (EMEA) in all 27 European Union member states, Mexico and Iceland. On January 20th, Victoza was also approved in Japan. A New Drug Application was submitted for China in August 2009, regulatory decision is pending.

Indications and Usage

Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.  It has not been studied sufficiently in patients with a history of pancreatitis.  Victoza should not be used to treat type 1
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SOURCE Novo Nordisk
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