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

e the risk of hypoglycemia.  

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza or any other antidiabetic drug.

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.

Victoza has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

Victoza should be used with caution in patients with renal impairment and in patients with hepatic impairment.

About Type 2 Diabetes

Approximately 220 million people worldwide have diabetes, the vast majority of which is type 2 which is caused by a combination of insulin resistance and inadequate and progressive dysfunction of the cells (beta cells) that produce and release insulin.  In fact, studies show that 50% of beta-cell function is lost by the time of diagnosis.  In the U.S. alone, approximately 24 million people have type 2 diabetes.  Despite the availability of many treatments, close to 45% of people with type 2 diabetes are not achieving A1C goals.  Lack of glycemic control puts patients at serious risk; for every 1% increase in A1C above 6%, the risk of death increases by 20%.

Further complicating the disease, 85% of people with type 2 diabetes are overweight or obese, and obesity increases insulin resistance, cardiovascular risk, and mortality. People with type 2 diabetes are at high risk of cardiovascular disease and have higher morbidity and mortality when cardiovascular events occur.

As the burden of type 2 diabetes continues to grow, innovation in developing drugs and improving health care delivery is needed if th
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