Saxenda Now Approved for the Treatment of Obesity

American Society of Bariatric Physicians Applauds Approval

Cited comments by: Joseph Prioetto, MB, BS, PhD -- Eric C. Westman, MD -- Deborah Bade Horn, DO -- James Smith, MD, MS

Saxenda (liraglutide [rDNA origin] injection) is now approved for chronic weight management in addition to a reduced-calorie diet and physical activity in adults with a body mass index (BMI) of ≥30 kg/m2 or ≥27 kg/m2 plus at least one weight-related condition (eg, hypertension, type 2 diabetes, or dyslipidemia).

Saxenda, which is manufactured by Novo Nordisk, is a human glucagon-like peptide-1 (GLP-1) receptor agonist that is given by subcutaneous injection and also is approved for the treatment of type 2 diabetes. GLP-1 helps regulate appetite and calorie intake, and the GLP-1 receptor is present in areas of the brain involved in appetite regulation, including the hypothalamus.

“Pharmacotherapy to suppress hunger is essential to maintain weight loss long term as the body vigorously defends weight,” said Joseph Proietto, MB BS, PhD, Head of the Weight Control Clinic Austin Hospital, Australia. Dr. Proietto was the lead investigator of the phase 3 SCALE trial of liraglutide for weight management.

Saxenda Reduces Body Weight By ≥5% in the Majority of Patients
Approval was based data from 3 clinical trials involving approximately 4,800 overweight and obese patients. In the SCALE trial (n=2,590), liraglutide 3 mg in combination with diet and exercise was associated with a significantly greater reduction in BMI at 56 weeks (8% vs. 2.6% with placebo; P<0.0001). In addition, a significantly greater proportion of patients in the liraglutide group achieved a ≥5% reduction in body weight (64% vs. 27%; P<0.0001) or a >10% reduction in body weight (33% vs. 10%; P<0.0001) compared with the placebo group.

The most common side effects in this study were nausea and diarrhea. Approximately 10% of the Saxenda group and 4% of the placebo group withdrew from the study early, primarily because of gastrointestinal adverse events.

Serious side effects reported in clinical trials of Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda should be discontinued in patients who experience a sustained increase in resting heart rate. Saxenda should not be used in combination with any other GLP-1 receptor agonists that are used for the treatment of type 2 diabetes, such as Victoza.

In addition, the prescribing information for Saxenda contains a boxed warning stating that 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 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).

American Society of Bariatric Physicians Applauds Approval
The approval “marks another milestone in the health care industry,” said Eric C. Westman, MD, President of the American Society of Bariatric Physicians. “There is undoubtedly a need for medical obesity treatment options, and patients now have more options than ever to discuss with their physicians,” Dr. Westman said.

“There is no universal cure for obesity,” said ASBP President-elect Deborah Bade Horn, DO. “Individuals affected by obesity need medical treatment options personalized to them, and having another medication to use for treatment certainly helps clinicians provide effective, individualized care,” Dr. Horn said.

“Obesity is a public health concern and threatens the overall well-being of patients,” said James Smith, MD, MS, Acting Deputy Director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “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,” Dr. Smith said.

Saxenda is the fourth FDA-approved weight-management medication available for use. Other medications currently on the market include Belviq from Eisai Inc., Qsymia from Vivus Inc., and Contrave from Takeda Pharmaceuticals.

March 19, 2015

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