Saxenda FDA-approved for Chronic Weight Management

Cited Comments by: Joseph Proietto, MB BS, PhD

Saxenda (liraglutide injection) is now approved for chronic weight management in addition to a reduced-calorie diet and physical activity in adults who are obese or who are overweight and have at least 1 weight-related condition (eg, high blood pressure, type 2 diabetes, or abnormal lipids).

Saxenda, which is manufactured by Novo Nordisk, is in a class of medications called human glucagon-like peptide-1 (GLP-1) receptor agonists and works by decreasing feelings of hunger and controlling how much you eat. Saxenda also is approved for the treatment of diabetes.

“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.

The U.S. Food and Drug Administration based the approval on studies showing that Saxenda was linked to greater reductions in body weight compared with people who received a placebo injection. In the SCALE trial, 64% of people had a ≥5% decrease in body weight with 1 year of treatment compared with 27% of people who received placebo. All of the people in the study were asked to follow a low calorie diet and exercise program.

Potential Common Side Effects
The most common side effects of Saxenda are nausea and diarrhea. Serious side effects reported in clinical trials of Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda has also been found to cause 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 tumors of the thyroid gland were found in animal studies, but that it is unknown whether Saxenda causes these tumors in humans. Saxenda should not be used in patients with a personal or family history of a thyroid cancer called medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2 (a disease that causes tumors in more than one gland in the body).

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.

March 19, 2015

Sources

American Society of Bariatric Physicians. Obesity medicine physicians encouraged by FDA approval of weight-management drug, Saxenda. December 5, 2014. http://www.asbp.org/about/news/110-obesity-medicine-physicians-encouraged-by-fda-approval-of-weight-management-drug-saxenda.html. Accessed March 19, 2015.

Novo Nordisk. Saxenda for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee. September 11, 2014. http://press.novonordisk-us.com/index.php?s=20295&item=122784. Accessed March 19, 2015.

Novo Nordisk. Phase 3a data from largest trial with liraglutide 3 mg demonstrated significantly greater weight loss versus placebo for adults with obesity. May 14, 2014. http://press.novonordisk-us.com/2014-05-16-Phase-3a-data-from-largest-trial-with-liraglutide-3-mg-demonstrated-significantly-greater-weight-loss-versus-placebo-for-adults-with-obesity. Accessed March 19, 2015.

Proietto J, le Roux CW, Pi-Sunyer X, et al. Efficacy and safety of liraglutide 3.0 mg for weight management in overweight and obese adults: The SCALE obesity and prediabetes, a randomised, double-blind and placebo-controlled trial. Obes Res Clin Pract. 2014;8(1):117.

Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015.

Sumithran P, Prendergast LA, Delbridge E, et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011;365(17):1597-1604.

U.S. Food and Drug Administration. FDA approves weight-management drug Saxenda. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm. Accessed March 19, 2015.

Continue Reading

Vyvanse® Approved for Binge-Eating Disorder in Adults