News
Wed, 22 Apr 2015 09:05:00 -0400
Wed, 22 Apr 2015 09:05:00 -0400
PLAINSBORO, N.J., April 22, 2015 /PRNewswire/ -- Novo Nordisk today announced that Saxenda®(liraglutide [rDNA origin] injection) is now available in the United States. Saxenda® is the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults. It is indicated inthe United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI >30 kg/m2) or who are overweight (BMI >27 kg/m2) in the presence of at least one weight-related comorbid condition.
Recently recognized as a disease by the American Medical Association and other medical societies, obesity has grown in prevalence in the United States and around the world.1-5 In fact, approximately 35% of the U.S. adult population lived with obesity in 2011 to 2012.6,7
"Novo Nordisk is pleased to offer a new treatment that can provide some patients who have obesity or are overweight with comorbidities a new path to achieving clinically meaningful weight loss," said Jesper Hoiland, President of Novo Nordisk Inc. "We believe the launch of Saxenda® represents a significant contribution to the therapeutic options that are advancing obesity care. For Novo Nordisk, it also aligns with our long-term commitment to help patients with chronic disease."
Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical program, which involved more than 5,000 study participants who have obesity (BMI >30 kg/m2) or who are overweight (BMI >27 kg/m2) with weight-related comorbidities. Trial data showed that Saxenda®, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss in some patients than reduced-calorie diet and physical activity alone.8
"Diet and increased physical activity are important and should be part of any weight-loss program; however, for some people with obesity a pharmacotherapy treatment option like Saxenda® may be needed to help them with chronic weight management," said Dr. Ken Fujioka, Department of Nutrition and Metabolic Research, Scripps Clinic, La Jolla, California, and a SCALE™ clinical trial investigator.
Indications and Usage
Limitations of Use
Important Safety Information
WARNING: RISK OF THYROID C-CELL TUMORS
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda®causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Saxenda® and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda®.
Contraindications
Saxenda® is contraindicated in the following conditions:
Warnings and Precautions
Adverse Events
Drug Interactions
Use in Specific Populations
About obesity
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.4,5 In 2011 to 2012 in the United States, approximately 35% of adults, or nearly 80 million adults, lived with obesity.6
About Saxenda®
Saxenda® is a once-daily glucagon-like peptide-1 (GLP-1) receptor analog with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda® regulates appetite and lowers body weight through decreased food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose. Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial program, which involved more than 5,000 study participants who have obesity (BMI >30 kg/m2) or who are overweight (BMI >27 kg/m2) with weight-related comorbidities.8
Saxenda® was approved by the FDA on December 23, 2014, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI >30 kg/m2) or who are overweight (BMI >27 kg/m2) with at least one weight-related comorbidity.9
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
References
1 American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. AccessedSeptember 8, 2014.
2 Mechanick JI, Garber AJ, Handelsman Y, Garvey WT. American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract. 2012;18(5):642-648.
3 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25_PA):2985-3023.
4 World Health Organization. Fact sheet no. 311: obesity and overweight.http://www.who.int/mediacentre/factsheets/fs311/en/. Updated August 2014. Accessed August 11, 2014.
5 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
6 Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
7 Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of comorbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(88):1471-2458.
8 Saxenda [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2015.
9 Data on file. Novo Nordisk Inc; Plainsboro, NJ.
Saxenda® is a registered trademark and SCALETM is a trademark of Novo Nordisk A/S.
© 2015 Novo Nordisk All rights reserved. 0315-00025949-1 April 2015
Saxenda® is a registered trademark and SCALETM is a trademark of Novo Nordisk A/S.
© 2015 Novo Nordisk All rights reserved. 0315-00025949-1 April 2015