United States first country to launch Saxenda®

Novo NordiskNovo Nordisk today announced that Saxenda® (liraglutide 3 mg) is now available in the United States (US). Saxenda® is the first glucagon-like peptide-1 (GLP-1) receptor agonist for weight management, approved in the US, EU and Canada. In the US, it is indicated 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.(1)

Saxenda® was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity-Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme, 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 greater weight loss than reduced calorie diet and physical activity alone.(1)

"We are pleased to make this new treatment option available, which we believe has the potential to help people with obesity lose weight and reduce weight-related comorbidities" said Executive Vice President Jakob Riis, Marketing, Medical Affairs & Stakeholder Engagement of Novo Nordisk. "The launch of Saxenda is an important milestone in Novo Nordisk's long-term commitment to obesity treatment and we look forward to launching Saxenda in other countries later in 2015."

Recognised 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.(2-4) Affecting approximately 35% of the US adult population in 2011-2012, obesity is associated with serious co-morbidities, including type 2 diabetes, heart disease and certain types of cancer.(5,6)

Novo Nordisk expects to launch Saxenda® in several other markets starting in 2015.

About obesity
Obesity is a disease that requires chronic management.(3,7) It is associated with serious comorbidities including type 2 diabetes, heart disease, obstructive sleep apnoea (OSA), certain types of cancer and a decreased life expectancy.(6,8,9) The risk of morbidity and mortality increases with the severity of obesity.(10) It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors.(11) The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.(4,12) In 2011-2012 in the US, approximately 35% of adults, or nearly 80 million adults, lived with obesity.(5)

About Saxenda®
Saxenda® is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,(13) a hormone that is released in response to food intake.(14) Like human GLP-1, Saxenda® regulates appetite and lowers body weight through decreased food intake.(15,16) 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® has been approved by the US Food and Drug Administration, the European Commission and Health Canada.

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, and is now entering the obesity therapy area. Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 countries.

1. FDA. Saxenda® (liraglutide 3 mg) US Prescribing Information. January 2015. Available at: http://www.novo-pi.com/saxenda.pdf.
2. AMA. A.M.A Adopts New Policies on Second Day of Voting at Annual Meeting. Obesity as a Disease. Available at: http://www.ama-assn.org/ama/pub/news/news/2013/2013-06-18-new-ama-policies-annual-meeting.page Last accessed 10.04.15.
3. Mechanick JI, Garber AJ, Garvey WT. American Association of Clinical Enodocrinologists' Position Statement on Obesity and Obesity Medicine. Endocrine Practice. 2012; 18:642-648.
4. WHO. Obesity and Overweight Factsheet no. 311. Available at: http://www.who.int/mediacentre/factsheets/fs311/en/. Last accessed 10.04.15.
5. Ogden CL, Carroll MD, Kit BK, et al. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014; 311:806-814.
6. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009; 9:88.
7. 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. Circulation. 2014; 129:S102-138.
8. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea. Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.
9. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Annals of Internal Medicine. 2003; 138:24-32.
10. Bray GA, Bellanger T. Epidemiology, trends, and morbidities of obesity and the metabolic syndrome. Endocrine. 2006; 29:109-117.
11. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012; 37:730-732.
12. Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. Journal of Health Economics. 2012; 31:219-230.
13. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. Journal of Medicinal Chemistry. 2000; 43:1664-1669.
14. Orskov C, Wettergren A, Holst JJ. Secretion of the incretin hormones glucagon-like peptide-1 and gastric inhibitory polypeptide correlates with insulin secretion in normal man throughout the day. Scandinavian Journal of Gastroenterology. 1996; 31:665-670.
15. van Can J, Sloth B, Jensen CB, et al. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. International Journal of Obesity. 2014; 38:784-793.
16. Secher A, Jelsing J, Baquero AF, et al. The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. J Clin Invest. 2014; 124:4473-4488.

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