FDA Approves Weight-Loss Drug, Saxenda

The U.S. Food and Drug Administration (FDA) has approved a new injectable weight-loss drug, Saxenda (liraglutide), for obese adults or overweight adults with at least one weight-related health problem. Weight-related health conditions include hypertension, type 2 diabetes and high cholesterol.

"Obesity is a public health concern and threatens the overall well-being of patients," Dr. James Smith, acting deputy director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related comorbid condition."

To test the safety and effectiveness of Saxenda, which is manufactured by Novo Nordisk, researchers conducted three trials involving around 4,800 obese and overweight participants with and without weight-related health conditions. All of the participants received healthy lifestyle counseling on top of the drug.

In one trial, researchers found that non-diabetic participants on Saxenda lost an average of 4.5 percent in weight after one year. Out of the participants who were on the drug, 62 percent had lost at least five percent of their body weight. In the placebo group, only 34 percent of the people lost at least five percent of their body weight.

In the other trial, researchers found that type 2 diabetics had an average weight loss of nearly four percent after one year. Out of the people who received Saxenda, 49 percent of them lost at least five percent of their body weight. In the placebo group, only 16 percent achieved similar weight loss results.

Saxenda belongs to a class of drugs called glucagon-like peptide-1 receptor agonists. Patients should not take the drug in combination with other drugs in the same class. Doctors should assess the drug's effectiveness after 16 weeks. Patients who do not lose at least four percent of their body weight should not continue taking the medication.

Common side effects include nausea, diarrhea, constipation, low blood sugar and loss of appetite. More severe side effects are pancreatitis, gallbladder disease, increased heart rate, decreased kidney function and suicidal thoughts.