Novo Nordisk Receives FDA Approval of Saxenda® (liraglutide) injection 3 mg Label Update Including Long-Term Safety and Efficacy Data from 3-Year Trial

PLAINSBORO, N.J., April 27, 2017 /PRNewswire/ -- 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 SCALEtm (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

Important Safety Information

What is the most important information I should know about Saxenda^®?
Serious side effects may happen in people who take Saxenda^®, including:
Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda^® and medicines that work like Saxenda^® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Saxenda^® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not use Saxenda^®?
Do not use Saxenda^® if:

• you or any of your family have a history of MTC
• you have MEN 2. This is a disease where people have tumors in more than one gland in their body
• you are allergic to liraglutide or any of the ingredients in Saxenda^®. Symptoms of a serious allergic reaction may include: swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, and severe rash or itching

Talk with your health care provider if you are not sure if you are pregnant or planning to become pregnant. Saxenda^® may harm your unborn baby

Before taking Saxenda^®, tell your health care provider about all of your medical conditions, including if you:

• have any of the conditions listed in the section "What is the most important information I should know about Saxenda^®?"
• are taking certain medications called GLP-1 receptor agonists
• are allergic to liraglutide or any of the other ingredients in Saxenda^®
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had problems with your pancreas, kidneys or liver
• have or have had depression or suicidal thoughts
• are pregnant or plan to become pregnant. Saxenda^® may harm your unborn baby. Tell your health care provider if you become pregnant while taking Saxenda^®. If you are pregnant you should stop using Saxenda^®
• are breastfeeding or plan to breastfeed. It is not known if Saxenda^® passes into your breast milk. You and your health care provider should decide if you will take Saxenda^® or breastfeed. You should not do both without talking with your health care provider first

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Saxenda^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda^® may affect the way some medicines work and some other medicines may affect the way Saxenda^® works. Tell your health care provider if you take diabetes medicines, especially sulfonylurea medicines or insulin.

How should I use Saxenda^®?

• Inject your dose of Saxenda^® under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle
• Never share your Saxenda^® pen or needles with another person. You may give an infection to them, or get an infection from them

What are the possible side effects of Saxenda^®?
Saxenda^® may cause serious side effects, including:

• possible thyroid tumors, including cancer
• inflammation of the pancreas (pancreatitis). Stop using Saxenda^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
• gallbladder problems. Saxenda^® may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Call your health care provider if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), and clay-colored stools
• low blood sugar (hypoglycemia) in people with type 2 diabetes who also take medicines to treat type 2 diabetes. Saxenda^® can cause low blood sugar in people with type 2 diabetes who also take medicines used to treat type 2 diabetes (such as sulfonylureas). In some people, the blood sugar may get so low that they need another person to help them. If you take a sulfonylurea medicine, the dose may need to be lowered while you use Saxenda^®. Signs and symptoms of low blood sugar may include: shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, and feeling jittery. You should check your blood sugar before you start taking Saxenda^® and while you take Saxenda^®
• increased heart rate. Saxenda^® can increase your heart rate while you are at rest. Your health care provider should check your heart rate while you take Saxenda^®. Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes when taking Saxenda^®
• kidney problems (kidney failure). Saxenda^® may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth
• serious allergic reactions. Serious allergic reactions can happen with Saxenda^®. Stop using Saxenda^® and get medical help right away if you have any symptoms of a serious allergic reaction
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care provider right away if you have any mental changes that are new, worse, or worry you 

Common side effects of Saxenda^® include nausea, diarrhea, constipation, headache, vomiting, low blood sugar (hypoglycemia), decreased appetite, upset stomach, tiredness, dizziness, stomach pain, and changes in enzyme (lipase) levels in your blood. Nausea is most common when first starting Saxenda^®, but decreases over time in most people as their body gets used to the medicine. Tell your health care professional if you have any side effect that bothers you or that does not go away.

Please click here for prescribing information.

About Saxenda^®
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 SCALEtm (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).

About Obesity
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.

References
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.

Saxenda^® and Victoza^® are registered trademarks and SCALEtm is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk   All rights reserved.   USA17SAM01264   April 2017

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