Breakthrough for Novo Nordisk

In a major breakthrough, Denmark based Novo Nordisk (NVO - Snapshot Report) received US Food and Drug Administration (FDA) approval for Victoza (liraglutide), a once-daily injection for the treatment of type II diabetes in adults. The drug has been approved for use with proper diet, exercise and other diabetes medicines for lowering blood sugar levels. However, the FDA has not recommended Victoza as an initial therapy in patients who could not control diabetes with diet and exercise alone.
 
Following the approval of Victoza, Novo Nordisk will be required to carry out studies to provide additional information on the safety of this product. While Victoza was not associated with increased risk of cardiovascular ailments in people with low risk for such ailments, the company will have to conduct a cardiovascular safety study to evaluate the drug’s safety in a higher risk population.
 
In animal studies conducted with Victoza, rats and mice developed thyroid tumor leading to cancer in some cases. Due to this reason, the drug has not been approved for the first-line treatment of diabetes. Given the situation, Novo Nordisk has been asked to establish a cancer registry to monitor the occurrence of this type of cancer in the U.S. over the next 15 years.
 
Victoza has been approved with a Risk Evaluation and Mitigation Strategy (REMS), which will consist of a medication guide and a communication plan to ensure that patients and doctors are aware of the associated risks.
 
Although Victoza’s sales potential is limited since it has not been approved as first-line treatment, the drug scores over other medication with respect to weight gain. There is a huge unmet demand in the diabetes market where more than 1.5 million new cases are diagnosed annually.

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