FDA Gives Novo the Go-Ahead to Market Victoza® in the U.S.
Danish pharmaceutical company Novo Nordisk has received Food and Drug Administration permission to begin marketing its type 2 drug Victoza® in the United States.
Victoza, the brand name for liraglutide, is a GLP-1* analog that is taken one a day by injection to help control blood sugar-and in some cases, help with weight loss-in patients with type 2 diabetes.
The drug, which has already been marketed in Europe, is being offered as both a monotherapy and as an adjunct to other diabetes drugs that are taken orally.
In making the announcement, Novo repeated its caution that Victoza is not insulin and it is not known if the drug can be safely used with insulin. The company further warned that Victoza is not a therapy for people with type 1 diabetes or people with diabetic ketoacidosis, and that the drug is not recommended for use with children.
The FDA's approval comes in the wake of concerns that GLP-1 drugs like Victoza have been implicated in increased cases of pancreatitis, an inflammatory condition that can led to death. Novo, in attaching cautions to the drug's use, recommended that type 2s with gallstones, high triglyceride levels, alcoholism, or previous episodes of pancreatitis tell their doctors about these conditions when considering taking Victoza.
Other cautions included relating that lab rats and mice developed thyroid tumors, some of which were cancerous, when given the medicine in Victoza. However, it is not known whether the drug causes thyroid tumors in people.
Novo also said type 2 patients or their family members who have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a disease in which people have tumors in more than one gland in their body, should not use Victoza.
Victoza only stimulates pancreatic beta cells to produce insulin when blood glucose levels are high, making it unlikely to produce hypoglycemia in patients. However, if taken with an oral medication like a sulfonylurea, the combination could lead to hypoglycemia. Novo suggests that patients who do take Victoza with other diabetes drugs may want to lower the doses of those drugs to avoid episodes of too-low blood sugar.
Novo is currently testing an oral version of Victoza among 155 British patients with type 2. The hope is that an ingested rather than injected drug will be far more attractive to Victoza users.
The past year has seen Novo win extensive international approval for the drug. The 27-member European Union approved its sales on June 30, 2009, and Japan approved sales in January, 2010. Novo applied for marketing approval in China last August and is awaiting a decision.
*GLP-1-glucagon-like peptide-is a delicate gut hormone whose beneficial effects on the digestive system have made it one of the most promising diabetes therapies in modern times. Those effects include:
- Stimulation of insulin production
- Decrease of pancreatic glucagon production
- Increase in pancreas beta cell mass
- Inhibition of acid secretion and gastric emptying in the stomach
- Increased insulin sensitivity
- Increase in feelings of satiety, leading to less food intake
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Source: Novo Nordisk press release