New Type 2 Diabetes Injection Approved

1/27/2010
The FDA has approved Novo Nordisk’s Victoza (liraglutide) injection as an adjunct to diet, exercise, and other medications for the treatment of type 2 diabetes in some adults. Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist used as a once-daily injection that stimulates insulin production following a meal. The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) program that includes a Medication Guide and communication plan. The objectives of the communication plan are to help patients and health care providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer. Novo Nordisk is required to conduct a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher-risk population and a 5-year epidemiological study using health claim databases to evaluate thyroid and other cancer risks along with risks for hypoglycemia, pancreatitis, and allergic reactions. Novo Nordisk is also required to establish a US registry to monitor and evaluate the risk and rate of medullary thyroid cancer in patients taking Victoza over the next 15 years.
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