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| |  FDA Approves Once-Daily Liraglutide Injection for Type 2 Diabetes ROCKVILLE, Md -- January 26, 2010 -- The US Food and Drug Administration (FDA) has approved a once-daily liraglutide injection (Victoza) to treat type 2 diabetes in some adults. Liraglutide is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone. In 5 clinical trials involving more than 3,900 people, pancreatitis occurred more often in patients who took liraglutide than in patients taking other diabetes medicines. Liraglutide should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Liraglutide should be used with caution in people with a history of pancreatitis. The most common side effects observed with liraglutide were headache, nausea, and diarrhoea. Other side effects included allergic-like reactions such as hives. Liraglutide was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. The FDA approved liraglutide, however, with several post-marketing requirements to ensure that the company will conduct studies to provide additional information on the safety of this product. In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of liraglutide in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for hypoglycemia, pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years. In animal studies, liraglutide caused tumours of the thyroid gland in rats and mice who received excessive doses that were 8-times higher than what humans would receive. It is not known if liraglutide could cause thyroid tumours or medullary thyroid cancer in people. For this reason, liraglutide should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, liraglutide should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with Multiple Endocrine Neoplasia syndrome type 2. To ensure the safe and effective use of this product, liraglutide was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of liraglutide and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer.
SOURCE: US Food and Drug Administration
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