Saxenda Receives Expanded Approval for Weight Management

December 4, 2020 – The U.S. FDA has approved an expanded indication for Saxenda® (liraglutide) injection 3mg, manufactured by Novo Nordisk. First FDA approved in 2014 to provide chronic weight management for certain adults, the drug is now also indicated for use in adolescents 12-17 years of age. Adolescent patients must weigh more than 60kg (132 pounds) and have an initial body mass index (BMI) that corresponds to 30kg/m ² (obese) or greater for adults. Saxenda should be used as an adjunct to a reduced- calorie diet and increased exercise.

Approximately 20% of adolescents in the United States are considered obese, which increases their risk of diabetes, heart disease, cancer, mental health conditions, and other illnesses. Obesity in adolescence also increases the risk of obesity in adulthood. While diet and exercise play a key role in reducing excess weight and improving health, for some patients, these alone are not sufficient. Obesity is influenced by multiple factors that include genetics, appetite signals, behavior, and the individual’s environment. Medication can play an important role in a comprehensive treatment plan for certain patients.

In a clinical study, adolescent patients who received Saxenda saw, on average, a significant a reduction in their BMI standard deviation score (BMI SDS) at 56 weeks of treatment. Those who received a placebo had, on average, no reduction in their BMI SDS. Patients on Saxenda also experienced, on average, a 2.65% reduction in body weight while patients on placebo gained an average of 2.37% of their body weight.

Recommended initial dosing is dosing is 0.6mg per day for one week. The dose should then be increased at weekly intervals until a maintenance dose of 3mg per day is reached. Pediatric patients who are unable to tolerate 3mg daily may need a dose reduction to 2.4mg daily. Dose escalation may take up to eight weeks for pediatric patients. Administered as a subcutaneous injection, Saxenda can be injected by a caregiver or self-administered once an individual has been trained in proper injection technique by a healthcare professional.

According to a black box warning, Saxenda is contraindicated in patients who have a personal or family history of medullary thyroid cancer (MTC) or in patients diagnosed with multiple endocrine neoplasia syndrome type 2. The active pharmaceutical ingredient, liraglutide, is known to cause thyroid C-cell tumors in rats and mice, though it is not known whether Saxenda causes these tumors in humans.