After promising outcomes in clinical trials, the Food and Drug Administration (FDA) has approved the use of a new anti-obesity drug called Saxenda, which will be available by prescription to overweight and obese adults.
The injectable treatment — the second of its kind approved this year — helps to reduce hunger and regulate blood sugar levels, and appears to promote greater weight loss. Patients taking the drug, made by Novo Nordisk, should still follow a low-calorie diet and exercise regularly, the FDA noted.
“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 a statement.
“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,” said Dr. Smith.
Saxenda belongs to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. It works by stimulating insulin production and triggering the release of glucagon (a hormone produced by the body) from the pancreas. The drug also dampens appetite.
According to the FDA, Saxenda should not be used with any other drugs in this class, including Victoza — a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide), but Saxenda contains a larger dose of it.
Effectiveness of Saxenda demonstrated in clinical trials
Three clinical trials assessed the safety and effectiveness of the drug for weight loss. The trials involved roughly 4,800 obese and overweight people with and without other weight-related conditions, including hypertension (high blood pressure), type 2 diabetes, and dyslipidemia (high cholesterol). All of the participants were counseled about lifestyle changes, such as a low-calorie diet and regular exercise.
One clinical trial that involved patients without diabetes found that patients taking Saxenda had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) at one year. Of the people treated with the drug, 62 percent lost at least 5 percent of their body weight. Meanwhile, only 34 percent of those given an inactive placebo had the same result.
Another clinical trial that included patients with type 2 diabetes found that patients had an average weight loss of almost 4 percent from baseline compared to treatment with a placebo at one year. Of those given Saxenda, 49 percent lost at least 5 percent of their body weight, compared to 16 percent of those who were given a placebo treatment.
The FDA advises that patients should be examined to determine if Saxenda is working after 16 weeks of treatment. Those who do not lose at least 4 percent of their body weight by that time should stop taking the medication, the FDA said, as patients who fail to do so are “unlikely to achieve and sustain clinically meaningful weight loss with continued treatment.”
The most common side effects associated with Saxenda included nausea, diarrhea, constipation, vomiting, low blood sugar and loss of appetite. Other more serious side effects can include pancreatitis (infection of the pancreas), gallbladder disease, lowered kidney function, suicidal thoughts and increased heart rate, the agency noted. Patients who experience a prolonged increase in their resting heart rate should stop taking Saxenda, the FDA added.
The FDA has required that additional studies involving Saxenda investigate the safety and effectiveness of the drug in children, including how it could affect growth and development. They also called for an MTC case registry to be established to identify any possible increase in cases associated with Saxenda use over a minimum of 15 years. Ongoing clinical trials are also examining the possible risk of breast cancer associated with Saxenda.