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New Drug Approved
January 29, 2010
On January 25, the US Food and Drug Administration (FDA) approved the injectable diabetes medicine liraglutide (brand name Victoza), developed by Novo Nordisk. Victoza is the first once-daily treatment in the class of drugs known as GLP-1 agonists. (Exenatide [Byetta] is the other member of this drug class.)
GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependant mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).
In clinical trials, Victoza has been associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) and weight loss. It can be administered at any time during the day and is injected into the subcutaneous (below the skin) tissue of the abdomen, thigh, or upper arm using a prefilled pen device. Victoza is approved for use in adults with Type 2 diabetes.
This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). It is not recommended as a first-line therapy for people who have not achieved blood glucose control using diet and exercise.
Victoza should not be used in people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. (In preclinical testing, this medicine caused thyroid tumors in rats and mice.) The most common side effects in people using Victoza are headache, nausea, diarrhea, and the development of antibodies to the medicine.
Victoza is expected to be introduced into the US market within the next 4–6 weeks. For more information, see the Victoza Web site.
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