FDA Approves New Weight-Management Drug

The US Food and Drug Administration has approved Saxenda (liraglutide [rDNA origin] injection) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese (BMI 30 or greater) and overweight (BMI 27 or greater) adults who have at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.

Saxenda, manufactured by Novo Nordisk, is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of obesity.

In a news release from the FDA, James Smith, MD, MS, acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, said, “Obesity is a public health concern and threatens the overall well-being of patients. 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.”

FDA approval for Saxenda was based on safety and efficacy data from 3 clinical trials that enrolled “approximately 4,800 obese and overweight patients with and without significant weight-related conditions.” In the trials, patients received counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity.

In one trial that did not include patients with diabetes, participants achieved an average weight loss of 4.5 percent from baseline compared to treatment with a placebo; 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo.

In another trial that included patients with diabetes, participants achieved an average weight loss of 3.7 percent from baseline compared to treatment with placebo after one year. Nearly half (49 percent) of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients who received placebo.

According to the FDA, Saxenda “should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes. Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively). However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established.”

It is recommended that treatment with Saxenda should be discontinued after 16 weeks if the patient has not lost at least 4 percent of their starting body weight.

The FDA also noted that Saxenda will include a boxed warning stating that “tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Saxenda but that it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Saxenda should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC).”

The most common side effects reported in clinical trials with Saxenda were nausea, diarrhea, constipation, vomiting, hypoglycemia, and decreased appetite. Serious side effects observed in some patients include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Treatment with Saxenda should be discontinued in patients who experience sustained increase in resting heart rate.

As a condition of approval, the FDA is requiring several additional studies to evaluate Saxenda dosing, safety, and efficacy in pediatric patients. Novo Nordisk will also create an MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda. Researchers will also evaluate the potential risk of breast cancer with Saxenda in ongoing clinical trials.

Saxenda was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda.