Cardiovascular safety data added to Saxenda® label

Saxenda® is the first and only FDA-approved medicine in a pen indicated to help adults lose weight and keep it off

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Oct 22, 2018, 12:46 ET

PLAINSBORO, N.J., Oct. 22, 2018 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda^® (liraglutide) injection 3 mg. The label now includes some data from the landmark LEADER trial (NCT01179048) that show the same active ingredient found in Saxenda^®, at a lower dose, liraglutide 1.8 mg, did not increase the risk of major adverse cardiovascular (CV) events, (non-fatal heart attack, non-fatal stroke and CV death) in adults with type 2 diabetes and established CV disease.

Saxenda® (liraglutide injection 3 mg) pens. Please see full Prescribing Information for Saxenda® at Saxenda.com

"The addition of these clinical data to the Saxenda^® label underscores Novo Nordisk's commitment to providing much-needed treatment options for people living with the serious and chronic disease of obesity," said Anne Phillips, MD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs for Novo Nordisk. "These cardiovascular data may be informative for health care professionals in their clinical decision-making when determining a safe, effective and comprehensive treatment approach for patients trying to lose weight and keep it off."

Obesity is recognized as a disease that requires long-term management by leading organizations, including the American Medical Association, the World Obesity Federation, The Obesity Society and many others.^1-4 Today, obesity affects about four in 10 adult Americans, and is a major risk factor for the development of multiple disorders, including cardiovascular disease, as well as hypertension, dyslipidemia and type 2 diabetes.^5,6

"Obesity is a real disease affecting real people who deserve real care," said Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham. "People with obesity often do try hard to lose weight on their own, but metabolic and hormonal responses affect the ability to maintain weight loss. That's why it's paramount that we continue to develop treatment options that address critical aspects of chronic weight management and the various health factors that contribute to this disease."

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 see Prescribing Information and Medication Guide for Saxenda^® at www.novo-pi.com/saxenda.pdf.

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. 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 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 biologic-based chronic disease requiring long-term management.¹ Obesity is influenced by genetic, physiological, environmental and psychological factors and is associated with many serious health consequences.^7,8

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.^9,10 In the United States, 38% of adults, or more than 95 million adults, live with obesity.⁵ 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.¹¹

About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

Further information
Media:
Liz Skrbkova (US)	+1 609 917 0632	[email protected]
Katrine Sperling	+45 4442 6718	[email protected]

Investors:
Peter Hugreffe Ankersen	+45 3075 9085	[email protected]
Christina Kjær	+45 3079 3009	[email protected]
Anders Mikkelsen	+45 3079 4461	[email protected]

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¹ 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 October 16, 2018.

² Bray GA, Kim KK, Wilding JPH. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obesity Reviews. May 2017.

³ 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.

⁴McKinney L. Diagnosis and Management of Obesity. American Academy of Family Physicians (AAFP). https://www.aafp.org/dam/AAFP/documents/patient_care/fitness/obesity-diagnosis-mono.pdf

⁵Obesity and overweight. Centers for Disease Control and Prevention website. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Updated June 13, 2016. Accessed October 16, 2018.

⁶Bays HE, Seger JC, Primack C, et al. Obesity algorithm 2016-2017. Presented by the Obesity Medicine Association. https://obesitymedicine.org/obesity-algorithm. Accessed October 16, 2018.

⁷Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732.

⁸Guh 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.

⁹World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated June 2016. Accessed October 16, 2018.

¹⁰ Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.

¹¹Crawford 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