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

diabetes mellitus or diabetic ketoacidosis. It has not been studied in combination with insulin.    

About Victoza

Victoza is the first and only human GLP-1 analog with 97% homology to natural GLP-1. Like natural 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.

In clinical studies submitted for FDA review, Victoza's® safety and efficacy were evaluated in five trials, one of 52-weeks duration and four of 26-weeks duration.  These multinational trials evaluated Victoza in monotherapy as well as in combination with one or two oral anti-diabetic medications and showed better lowering of blood glucose than active comparators such as sulfonylureas and thiazolidinediones.  A1C reductions for Victoza 1.8 mg, in combination or as monotherapy, ranged from 1.0% to 1.5% across the five clinical studies with baselines ranging from 8.2% to 8.6%.  Victoza 1.8 mg + metformin reduced A1C by 1.0% and reduced weight by 6.2lbs.  The most common adverse reactions reported in patients treated with Victoza are headache, nausea, diarrhea, and anti-liraglutide antibody formation.  Immunogenicity-related events, including urticaria, were more common among Victoza-treated patients than among comparator-treated patients in clinical trials.

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

Conference call

On January 26, 2010 at 08:00 am CET, corresponding to 02:00 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor
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SOURCE Novo Nordisk
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