Novo Nordisk receives Health Canada approval for Saxenda® (liraglutide) for the treatment of chronic weight management

MISSISSAUGA, ON, Feb. 26, 2015 /CNW/ - Novo Nordisk today announced that Health Canada has approved the New Drug Submission for Saxenda^® (liraglutide), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of chronic weight management.

Saxenda^® (liraglutide) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:

• 30 kg/m2 or greater (obese), or;
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.¹

"Many people with obesity suffer from comorbidities. Saxenda^® has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

The Saxenda^® approval in Canada follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion under the European Medicines Agency (EMA) on 22 January 2015 and the US Food and Drug Administration (FDA) approval of Saxenda^® in the US on 23 December 2014.

About obesity

Obesity is a chronic condition that is associated with serious comorbidities including hypertension, type 2 diabetes mellitus, dyslipidemia, certain types of cancer and a decreased life expectancy. The risk of morbidity and mortality increases with the severity of obesity. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.²

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In Canada, approximately 25 per cent of adults,³ equivalent to approximately 6.5 million people, live with obesity.

About Saxenda^®

Saxenda^® (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97 per cent 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 Non-diabetic and Diabetic people) phase 3 clinical trial program, which involved more than 5,000 people with obesity (BMI ≥30 kg/m²) or who were overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity.¹

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.

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1} Saxenda® (liraglutide), Novo Nordisk Canada Inc., Product Monograph, 26 February 2015.
² Multimorbidity in a prospective cohort: Prevalence and associations with weight loss and health status in severely obese patients. Obesity (Silver Spring). 2015 Mar;23(3):707-12. doi: 10.1002/oby.21008. Epub 2015 Feb 13. Accessed 26 February 2015.
³ Public Health Agency of Canada & Canadian Institute for Health Information. Obesity in Canada, 20 June 2011. Accessed 26 February 2015.

SOURCE Novo Nordisk Canada Inc.

For further information: Media: Jeremy Brace, [phone], [email protected]; Jacqueline Zonneville, [phone], [email protected]; Katrine Sperling, [phone], [email protected]; Investors: Kasper Roseeuw Poulsen, [phone], [email protected]; Jannick Lindegaard Denholt, [phone], [email protected]; Daniel Bohsen, [phone], [email protected]; Melanie Raouzeos, [phone], [email protected]; Frank Daniel Mersebach (US), [phone], [email protected]