FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17
FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17 Saxenda® (liraglutide) injection 3 mg becomes the first FDA-approved therapy to treat obesity in adolescents in more than a decade |
[04-December-2020] |
PLAINSBORO, N.J., Dec. 4, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda® (liraglutide) injection 3 mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to reduced-calorie meals and increased physical activity. Saxenda® was approved in 2014 for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased physical activity.1 Over the last 20 years, the global prevalence of children and adolescents with excess weight has doubled from 1 in 10 to 1 in 5.2 Research also shows that when both parents have excess weight, 80% of their children will have obesity.3 However, current treatment options for this population are limited, highlighting a considerable and growing need for additional treatment strategies.4 "New options to treat adolescents who live with obesity can bring much-needed hope to families and help address this growing epidemic," said Dr. Aaron Kelly, Professor of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota. "With up to 90 percent of adolescents with obesity likely to have it as adults and thus at increased risk for developing weight-related complications, it's important to address weight care and offer support early on.3,5 I'm encouraged that healthcare providers now have another tool in developing a personalized, complete care plan to help adolescents lose weight and keep it off." The safety and efficacy of Saxenda® as a treatment for adolescents with obesity is supported by data from a phase 3a trial published earlier this year in the New England Journal of Medicine. The 56-week clinical trial investigated the effects of Saxenda® compared to placebo for weight management in 251 patients aged 12-17 living with obesity as an adjunct to lifestyle therapy, defined as counselling in healthy nutrition and physical activity for weight loss. In the trial, the primary endpoint was change from baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) at week 56.6 The data demonstrated a significant reduction in BMI-SDS, as well as reductions in BMI, mean body weight, and other weight-related endpoints vs. placebo in adolescents with obesity when using Saxenda® as an adjunct to lifestyle therapy. Adverse events seen in an adolescent population were similar to those observed in adults. The most common adverse reactions were gastrointestinal events, including nausea, vomiting and diarrhea.6 "The rise in adolescent obesity is contributing to a public health crisis, and it poses a real challenge for healthcare professionals due to the limited treatment options available," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "We are proud to be able to offer a new treatment option for adolescents with obesity and their families in the US, as the FDA approval marks another significant milestone for Saxenda®." What is Saxenda®? Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® should be used with a reduced calorie diet and increased physical activity.
Important Safety Information Do not share your Saxenda pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. What is the most important information I should know about Saxenda®? Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that work like Saxenda® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use Saxenda® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Who should not use Saxenda®?
Before taking Saxenda®, tell your health care provider about all of your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Saxenda® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda® may affect the way some medicines work and some other medicines may affect the way Saxenda® works. Tell your health care provider if you take diabetes medicines, especially insulin and sulfonylurea medicines. How should I use Saxenda®?
What are the possible side effects of Saxenda®?
The most common side effects of Saxenda® in adults include nausea, diarrhea, constipation, vomiting, injection site reaction, low blood sugar (hypoglycemia), headache, tiredness (fatigue), dizziness, stomach pain, and change in enzyme (lipase) levels in your blood. Additional common side effects in children are fever and gastroenteritis. Please see Prescribing Information and Medication Guide for Saxenda® at www.novo-pi.com/saxenda.pdf. About the phase 3 trial (NCT02918279) The trial investigated the effect of Saxenda® (liraglutide 3.0 mg or maximum tolerated dose) compared to placebo for weight management in 251 adolescents (aged 12 to <18 years) living with obesity as an adjunct to lifestyle therapy.6 The trial included a 12-week run-in period of lifestyle therapy, a 56-week treatment period (including dose escalation over 4 to 8 weeks) on Saxenda® or placebo and a 26-week follow-up period without Saxenda® or placebo.6 All participants received lifestyle therapy beginning with the run-in period and during the 56-week treatment period and 26-week follow-up period.6 The phase 3a trial was a post-marketing requirement of the FDA under the Pediatric Research Equity Act (PREA), which aims to ensure treatments are safe and effective for children and adolescents.7,8 About Saxenda® Saxenda® is already indicated in the US for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced-calorie meal plan and increased physical activity.1 About obesity About adolescent obesity About Novo Nordisk References 1 US Food and Drug Administration (FDA). Saxenda® Prescribing Information. December 2020. 2 UNICEF. The state of the world's children 2019. Available at: https://www.unicef.org/media/60806/file/SOWC-2019.pdf. Last accessed: November 2020. 3 Lifshitz F. Obesity in Children. J Clin Res Pediatr Endocrinol. 2008 Dec; 1(2): 53–60 4 Cardel M, Jastreboff A, Kelly A. Treatment of Adolescent Obesity in 2020. JAMA. 2019; 322:1707–1708. 5 Gordon-Larsen P, The NS, Adair LS. Longitudinal Trends in Obesity in the United States from Adolescence to the Third Decade of Life. Obesity. 2010; 18 (9): 1801-1804 6 Kelly A, Auerbach P, Barrientos-Perez M. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1916038. NEJM. 2020;DOI: 10.1056/NEJMoa1916038 7 Novo Nordisk. Data on File. 8 Center for Drug Evaluation and Research. Pediatric Research Equity Act. U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-resources/pediatricresearch-equity-act-prea. Last accessed: November 2020. 9 American Medical Association. A.M.A Adopts New Policies on Second Day of Voting at Annual Meeting. Obesity as a Disease. Available at: http://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649. Last accessed: November 2020. 10 Bray GA, Kim KK, Wilding JPH. World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. ObesRev. 2017;18(7):715-723. doi:10.1111/obr.12551. 11 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732. 12 Bays HE, McCarthy W, Christensen S, et al. Obesity Algorithm, presented by the Obesity Medicine Association. Available at: https://obesitymedicine.org/obesity-algorithm/. Last Accessed: November 2020. 13 Finer N, Garnett SP and Bruun JM. COVID-19 and obesity. Clin Obes. 2020; 10:e12365. 14 Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the Patient with Obesity - The Editors Speak Out. Obesity. 2020; 28:847. 15 Centers for Disease Control and Prevention. Adult Obesity Facts. Available at: https://www.cdc.gov/obesity/data/adult.html. Updated June 29, 2020. Last accessed: November 2020. 16 World Health Organization. Childhood overweight and obesity. Available at: https://www.who.int/dietphysicalactivity/childhood/en/. Last accessed: November 2020. 17 World Health Organization. Obesity and overweight. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Last accessed: November 2020. 18 Centers for Disease Control and Prevention. Childhood Overweight and Obesity. Available at: https://www.cdc.gov/obesity/childhood/index.html. Updated September 11, 2018. Last accessed: November 2020. 19 Centers for Disease Control and Prevention. Childhood Obesity Facts. Available at: https://www.cdc.gov/obesity/data/childhood.html. Updated June 24, 2019. Last accessed: November 2020.
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