Two months after its own deadline, the U.S. Food and Drug Administration (FDA) issued approval for Novo Nordisk’s first weight-loss therapy.
Approved was Novo’s Saxenda for use in managing weight in conjunction with diet and exercise. Saxenda is a higher dose of the diabetes treatment liraglutide. The drug is indicated for patients who qualify as obese, with a body mass index (BMI) over 30, and those with BMIs of at least 27 who also have one or more weight-related conditions, such as hypertension.
In one Phase III trial, Saxenda helped 92 percent of overweight subjects lose weight compared with 62 percent on diet and exercise alone, and patients who completed the 56-week study lost an average of 9.2 percent of their body weight, significantly more than the 3.5 percent who took a placebo.