Saxenda® for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee

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Sep 11, 2014, 08:49 ET

WASHINGTON, Sept. 11, 2014 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda^®, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity.

Based on the data contained in the NDA for Saxenda^®, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of Saxenda^® for chronic weight management. Furthermore, the panel members were asked to discuss the safety database for Saxenda^® for chronic weight management, given the extent of clinical trial and post-marketing experience with liraglutide for diabetes mellitus with doses up to 1.8 mg per day.

The panel members voted 14-1 that the overall benefit-risk assessment Saxenda^® was favorable and supports approval for chronic weight management in individuals with a body mass index (BMI) 30 kg/m² or greater, or 27 kg/m² or greater in the presence of at least one weight-related comorbidity.

"We are pleased with the clear recommendation from the Advisory Committee," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We look forward to working with the FDA as they complete their review of Saxenda^®. Obesity is a serious public health issue in the U.S. and we are committed to making Saxenda^® a new treatment option for adults with obesity."

The recommendation was based on data from clinical trials of Saxenda^®, including the phase 3 SCALE™ clinical trial program, which involved more than 5,000 people who have obesity (BMI >/=30 kg/m²), or who are overweight (BMI >/=27 kg/m²) with comorbidities.

The NDA was submitted to the FDA on December 20, 2013.¹ The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA review of the Saxenda^® NDA is October 20, 2014.

About FDA Advisory Committee meetings
FDA Advisory Committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the Committee's recommendation, but it takes its advice into consideration when reviewing New Drug Applications. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer drugs to an Advisory Committee meeting, or alternatively justify why an Advisory Committee meeting was not requested.²

About obesity
Obesity is a disease^3,4 that requires chronic management.⁵ It is associated with serious comorbidities⁶ including type 2 diabetes, heart disease, obstructive sleep apnea (OSA), certain types of cancer^7,8 and a decreased life expectancy.^9,10 The risk of morbidity and mortality increases with the severity of obesity.^7,10 It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.¹¹

The global increase in the prevalence of obesity¹² is a public health issue that has severe cost implications to health care systems.¹³ In the U.S., approximately 35% of adults, or some 100 million people, live with obesity.^14,15

About Saxenda^®
Saxenda^®(liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,¹⁶ a hormone that is released in response to food intake. Like human GLP-1, Saxenda^®regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.17 The dual actions of Saxenda^® on both appetite and blood glucose regulation (for adults with pre-diabetes or type 2 diabetes) hold therapeutic potential for adults with obesity, both those with and without type 2 diabetes.^17,18

Saxenda^®is an investigational product and is not approved by the FDA or European Medicines Agency (EMA).

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 40,700 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.

For further information

Media:
Katrine Sperling	+45 3079 6718	[email protected]
Ken Inchausti (U.S.) Sharon Corbitt (U.S.)	+1 609 514 8316 +1 609 578 9974	[email protected] [email protected]
Investors:
Kasper Roseeuw Poulsen	+45 3079 4303	[email protected]
Jannick Lindegaard Denholt	+45 3079 8519	[email protected]
Daniel Bohsen	+45 3079 6376	[email protected]
Frank Daniel Mersebach (U.S.)	+1 609 235 8567	[email protected]

References

¹ Data on file. Novo Nordisk Inc; Plainsboro, NJ.
² United States Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007.
³ 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. Accessed September 8, 2014.
⁴ 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.
⁵ Hill JO. Dealing with obesity as a chronic disease. Obes Res. 1998;6(S1):34S-38S.
⁶Guh 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.
⁷ Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999;282(16):1523-1529.
⁸ Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea. Endocrinol Metab Clin North Am. 2003;32(4):869-894.
⁹ Whitlock G, Lewington S, Sherliker P, et al. Prospective Studies Collaboration: Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009;373(9669):1083-1096.
¹⁰ Peeters A, Barendregt JJ, Willekens F, Mackenbach JP, Al Mamun A, Bonneux L. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003;138(1):24-32.
¹¹ Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012; 37(5):730-732.
¹² 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.
¹³ Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
¹⁴ Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
¹⁵ Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. Washington, DC: National Center for Health Statistics, Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2012.
¹⁶ Russell-Jones D, Gough S. Recent advances in incretin-based therapies. Clin Endocrinol. 2012;77(4):489-499.
¹⁷ Flint A, Raben A, Ersbøll AK, Holst JJ, Astrup A. The effect of physiological levels of glucagon-like peptide-1 on appetite, gastric emptying, energy and substrate metabolism in obesity. Int J Obes Relat Metab Disord. 2001;25(6):781-792.
¹⁸ van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WHM. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults [published online ahead of print October 1, 2013]. Int J Obes. doi:10.1038/ijo.2013.162.