FDA Backs Injection for Obesity

 DDD MAG

Federal health experts say Novo Nordisk’s diabetes drug Victoza should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug’s benefits outweigh its risks for patients who are obese or dangerously overweight.

The FDA first approved Victoza in 2010 as a daily injection for type 2 diabetes, in which the body does not properly use insulin. The drug is part of a new class of medicines called GLP-1 agonists, which spur the pancreas to create extra insulin after meals.

Danish drugmaker Novo Nordisk now wants the FDA to approve the drug as an obesity treatment based on company studies showing significant weight loss in most patients.

Sixty percent of patients taking Victoza for over a year lost at least 5 percent of their body weight, and 31 percent of patients lost more than 10 percent, according to the company’s research. Among patients taking a sham treatment only 24 percent lost 5 percent of their body weight and 9 percent lost more than 10 percent. The FDA said the difference between the two was statistically significant and meets the agency’s criteria for effectiveness.

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