Novo Nordisk Receives FDA Approval of Saxenda® (liraglutide) injection 3 mg Label Update Including Long-Term Safety and Efficacy Data from 3-Year Trial
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- Published on Friday, 28 April 2017 09:26
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PLAINSBORO, NJ, USA I April 27, 2017 I Novo Nordisk today announced that the US Food and Drug Administration (FDA) approved an updated product label for Saxenda® (liraglutide) injection 3 mg, including data showing that approximately half of patients on Saxenda® (26% vs 10% on placebo) who lost more than or equal to 5% of their weight after 56 weeks (56% vs 25% on placebo) maintained their weight loss for 3 years. Study participants were adults with obesity (body mass index [BMI] ≥30 kg/m2) or excess weight (BMI ≥27 kg/m2) with at least one weight related comorbidity, on a reduced calorie meal plan and increased physical activity.
These long-term study data reinforce the established safety profile of Saxenda® and are consistent with the safety data observed at 56 weeks.1 The most common side effects were gastrointestinal (nausea and diarrhea) and more frequent with Saxenda® treatment than with placebo.
"We are pleased by the FDA's approval, which marks Saxenda® as the only weight-loss and management medicine in a pen supported by long-term safety and efficacy data. The addition of this clinical data to the Saxenda® label underscores Novo Nordisk's dedication to building a robust body of scientific evidence, highlighting the chronic, progressive nature of the disease of obesity. We continue in our long-term commitment to improve the lives of people with obesity by partnering with the community on education and advocacy, increasing access to care, and advancing medical management of the disease," said Dr. Todd Hobbs, vice president and chief medical officer at Novo Nordisk US.
The label update is based on data from the SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence in adults with and without Diabetes) Obesity and Pre-diabetes 3-year trial that investigated the long-term efficacy and safety of Saxenda®, in combination with a reduced-calorie meal plan and increased physical activity, in adults with pre-diabetes at screening.
All patients (n=3731) were treated for 56 weeks, and those with pre-diabetes (n=2254) were treated for 160 weeks. Patients were stratified at a 2:1 ratio to Saxenda® arm or placebo arm. The study evaluated the maintenance of weight loss of at least 5% of body weight. At 160 weeks, the amount of people with a weight assessment was 50% in the Saxenda® arm and 43% in the placebo arm.
Eligible patients with commercial insurance can use the Saxenda® Savings Card Program to reduce co-pays to as little as $30 or save up to $200 per Saxenda® prescription. The maximum benefit is $200 per prescription and up to 12 benefits annually. Eligibility and other restrictions apply. If you have questions regarding eligibility or benefits, visit www.saxendacoverage.com or call 1-888-809-3942. To download a savings card, visit https://www.saxenda.com/savings/Get-your-savings-card.html.
Indications and Usage
What is Saxenda®
Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Saxenda® should be used with a reduced-calorie meal plan and increased physical activity
- Saxenda® is not for the treatment of type 2 diabetes
- Saxenda® and Victoza® have the same active ingredient, liraglutide, and should not be used together
- Saxenda® should not be used with other GLP-1 receptor agonist medicines
- Saxenda® and insulin should not be used together
- It is not known if Saxenda® is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products
- It is not known if Saxenda® changes your risk of heart problems or stroke or of death due to heart problems or stroke
- It is not known if Saxenda® can be used safely in people who have had pancreatitis
- It is not known if Saxenda® is safe and effective in children under 18 years of age. Saxenda® is not recommended for use in children
Saxenda® (liraglutide) injection 3 mg is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist 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. Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program.
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 of ≥30 kg/m2) or who are overweight (BMI of ≥27 kg/m2) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Obesity is a chronic disease requiring long-term management.2 Complex and multifactorial in nature, obesity is influenced by genetic, physiological, environmental and psychological factors and is associated with many serious health consequences.3,4
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.5,6 In the United States, approximately 35% of adults, or nearly 79 million adults, live with obesity.7 Despite the high prevalence of obesity, many people with obesity lack support in their efforts to lose weight and the disease remains substantially underdiagnosed and underreported.8
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
1 Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017
2 American Medical Association House of Delegates. Recognition of obesity as a disease. Resolution 420 (A-13). http://www.npr.org/documents/2013/jun/ama-resolution-obesity.pdf. Received May 15, 2013. Accessed April 19, 2017.
3 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732.
4 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):1-20.
5 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated June 2016. Accessed April 19, 2017.
6 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
7 Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 1, 2016. Accessed April 19, 2017.
8 Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Type II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Health Manag. 2010;13:151–161.
SOURCE: Novo Nordisk