Novo Nordisk Inc. Release: New Analysis Of Data In Adults With Obesity Or Who Are Overweight With Weight-Related Comorbidities Showed Early Response To Saxenda (liraglutide [rDNA origin] injection) Predicted Greater Weight Loss

NASHVILLE, Tenn., May 15, 2015 /PRNewswire/ -- Today, new data from the phase 3a SCALE Obesity and Pre-diabetes trial were presented at the 24^th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (AACE), showing that adults with obesity or who are overweight with weight-related comorbidities and who had lost 4% or more of their body weight at 16 weeks (classified as “early responders,” n=1433) demonstrated greater weight loss after completing 56 weeks with Saxenda^® (liraglutide [rDNA origin] injection) treatment in combination with a reduced-calorie diet and increased physical activity, compared with those who had a weight loss of less than 4% at 16 weeks (“early nonresponders,” n=355). All treatment groups included a reduced-calorie diet and increased physical activity.¹

In the SCALE Obesity and Pre-diabetes trial, 77.3% of adults treated with Saxenda^® were early responders, compared to 30.5% (n=265) with placebo. At 56 weeks, Saxenda^® early responders who completed the trial achieved an average weight loss of 10.8%, compared with 3.0% in early nonresponders. Waist circumference (secondary end point) in early responders compared with early nonresponders was reduced by 10.5 cm and 4.8 cm, respectively.¹

“Not only were liraglutide 3 mg early responders more likely to achieve greater weight loss over time, they were also more likely to experience greater improvements in some secondary cardiometabolic risk factors and quality-of-life outcomes from their weight loss,” said Dr. David C.W. Lau, Professor of Medicine and Biochemistry & Molecular Biology at the University of Calgary and SCALE clinical trial investigator. “These findings demonstrate the predictive nature of an early response to treatment, which is important information clinicians can use to identify those patients who are likely to benefit the most from liraglutide 3 mg for chronic weight management.”

In addition to weight loss, early responders also demonstrated greater improvement across a range of secondary end points, including blood glucose control, cardiometabolic risk factors and health-related quality of life¹:

• A greater reduction in systolic/diastolic blood pressure was seen in Saxenda^® (liraglutide [rDNA origin] injection) early responders compared with early nonresponders (-5.1/-3.3 vs. -2.0/-1.4 mm Hg, respectively) and greater improvement in lipid levels, including triglycerides (-15.3 vs. -7.1%, respectively) and free fatty acids (1.2 vs. 6.7%, respectively).¹
• Quality-of-life scores (as measured by the Impact of Weight on QoL-Lite questionnaire) improved for Saxenda^® early responders compared with early nonresponders (rising by 12.7 vs. 8.2 points, respectively), driven primarily by increases in physical function scores.¹
• Early responders also experienced improvements in fasting plasma glucose compared with early nonresponders (-8.2 vs. -6.3 mg/dl, respectively) and in A1C (-0.36 vs -0.23%, respectively).¹

Across the SCALE clinical development program, Saxenda^® was generally well-tolerated.² Overall, the safety profiles of liraglutide 3 mg early responders and nonresponders were similar. The most common side effects observed were related to the gastrointestinal system. Similar proportions of early responders and early nonresponders experienced gastrointestinal disorders: 68.3 vs. 62.5%, respectively.¹

For events of special interest in obesity/weight management agents, adverse event rates were as follows (early responders vs. early nonresponders, respectively): gallbladder disorders: 2.7 vs. 1.1%; psychiatric disorders: 8.7 vs. 7.3%; and cardiac disorders: 3.2 vs. 4.8%, respectively.¹

Medication Guide
Saxenda^® (sax-end-ah) (liraglutide [rDNA origin] injection)

Read this Medication Guide and Patient Instructions for Use that come with Saxenda^® before you start using Saxenda^® and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have questions about Saxenda^® after reading this information, ask your healthcare provider or pharmacist.

What is the most important information I should know about Saxenda^®?

Serious side effects may happen in people who take Saxenda^®, including:

1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Saxenda^® caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Saxenda^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.

• Before you start taking Saxenda^®, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take Saxenda^® if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Saxenda^®(liraglutide [rDNA origin] injection).
• While taking Saxenda^®, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.

Before taking Saxenda^®, tell your healthcare provider if you have had:

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Saxenda^®.

While taking Saxenda^®:

Stop taking Saxenda^® and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

What is Saxenda^®?

• Saxenda^® is an injectable prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.
• Saxenda^® should be used with a reduced calorie diet and increased physical activity.
• Saxenda^® is not for the treatment of type 2 diabetes mellitus.
• Saxenda and Victoza^® (liraglutide [rDNA origin] injection) have the same active ingredient, liraglutide. Saxenda^® and Victoza^® 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.

Who should not use Saxenda^®?

Do not use Saxenda^® if:

• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (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^® (liraglutide [rDNA origin] injection). See the end of this Medication Guide for a complete list of 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
• severe rash or itching

Talk with your healthcare provider if you are not sure if you have any of these conditions.

• are pregnant or planning to become pregnant. Saxenda^® may harm your unborn baby.

What should I tell my healthcare provider before using Saxenda^®?

Before taking Saxenda^®, tell your healthcare provider 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^®. See the end of this Medication Guide for a list of 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 kidney or liver problems.
• have or have had depression or suicidal thoughts.
• have any other medical conditions.
• are pregnant or plan to become pregnant. Saxenda^® may harm your unborn baby. Tell your healthcare 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 healthcare provider should decide if you will take Saxenda^® or breastfeed. You should not do both without talking with your healthcare provider first.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription 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 healthcare provider if you take other diabetes medicines, especially sulfonylurea medicines or insulin.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use Saxenda^® (liraglutide [rDNA origin] injection)?

• Use Saxenda^® exactly as prescribed by your healthcare provider. Your dose should be increased after using Saxenda^® for 1 week until you reach the 3 mg dose. After that, do not change your dose unless your healthcare provider tells you to.
• Saxenda^® is injected 1 time each day, at any time during the day.
• You can take Saxenda^® with or without food.
• Your doctor should start you on a diet and exercise program when you start taking Saxenda^®. Stay on this program while you are taking Saxenda^®.
• Saxenda^® comes in a prefilled pen.
• Your healthcare provider must teach you how to inject Saxenda^® before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist. See the Patient Instructions for Use that come with this Medication Guide for detailed information about the right way to use your Saxenda^® pen.
• Pen needles are not included. Use the Saxenda^® pen with Novo Nordisk disposable needles. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.
• When starting a new prefilled Saxenda^® pen, you must follow the “Check the Saxenda^® flow with each new pen” (see the detailed Patient Instructions for Use that comes with this Medication Guide). You only need to do this 1 time with each new pen. You should also do this if you drop your pen. If you do the “Check the Saxenda^® flow with each new pen” before each injection, you will run out of medicine too soon.
• 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 healthcare provider. Do not inject into a vein or muscle.
• If you take too much Saxenda^®, call your healthcare provider right away. Too much Saxenda may cause severe nausea and vomiting.
• If you miss your daily dose of Saxenda^®, use Saxenda^® as soon as you remember. Then take your next daily dose as usual on the following day. Do not take an extra dose of Saxenda^® or increase your dose on the following day to make up for your missed dose. If you miss your dose of Saxenda^® for 3 days or more, call your healthcare provider to talk about how to restart your treatment.
• 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. See “What is the most important information I should know about Saxenda^®?”
• inflammation of the pancreas (pancreatitis). See “What is the most important information I should know about Saxenda^®?”
• gallbladder problems. Saxenda^® (liraglutide [rDNA origin] injection) may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms:
  • pain in your upper stomach (abdomen)
  • fever
  • yellowing of your skin or eyes (jaundice)
  • clay-colored stools
• low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat type 2 diabetes mellitus. Saxenda^® can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (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
  • feeling jittery

Talk to your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people who are around you a lot know how to recognize and treat low blood sugar. 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 healthcare provider should check your heart rate while you take Saxenda^®. Tell your healthcare provider 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 healthcare 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 See “Who should not use Saxenda^®?”
• 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 healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects of Saxenda^® (liraglutide [rDNA origin] injection) include:

• nausea
• diarrhea
• constipation
• low blood sugar (hypoglycemia)
• vomiting
• headache
• decreased appetite
• upset stomach
• tiredness
• dizziness
• stomach pain
• 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 healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects with Saxenda^®. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep your Saxenda^® pen, pen needles, and all medicines out of the reach of children.

General information about the safe and effective use of Saxenda^®.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Saxenda^® for a condition for which it was not prescribed. Do not give Saxenda^® to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information you should know about using Saxenda^®. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Saxenda^® that is written for health professionals.

What are the ingredients in Saxenda^®?
Active Ingredient: liraglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection

Please see saxenda.com for the Prescribing Information.

About obesity
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.^3,4 In 2011 to 2012 in the United States, approximately 35% of adults, or nearly 80 million adults, lived with obesity.⁵

About Saxenda^® (liraglutide [rDNA origin] injection)
Saxenda^® 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 AdiposityLiraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial program, which involved more than 5,000 study participants who have obesity (BMI >30 kg/m²) or who are overweight (BMI >27 kg/m²) with weight-related comorbidities.²

• In the US, Saxenda^® (liraglutide [rDNA origin] injection) 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 comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).²
• In the EU, Saxenda^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of >30 kg/m² (obese), or >27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnea.⁶
• In Canada, Saxenda^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial 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.⁷

About SCALE Obesity and Pre-diabetes
The SCALE Obesity and Pre-diabetes trial is a randomized, double-blind, placebo-controlled, multinational trial in non-diabetic adults with obesity and non-diabetic adults who are overweight with weight-related comorbidities. There were 3,731 participants randomized to treatment with Saxenda^® or placebo in combination with reduced-calorie diet and increased physical activity.² In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at baseline screening.⁷

The objectives of this trial were to demonstrate the efficacy of Saxenda^® compared with placebo, as well as to investigate the long-term potential efficacy of Saxenda^® to delay the onset of type 2 diabetes in participants with pre-diabetes at baseline screening.⁷

It is the largest of the phase 3a trials in the SCALE clinical development program, which encompassed more than 5,000 adults with obesity or adults who are overweight with weight-related comorbidities.⁷

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 defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information

References

¹ Lau DCW, Bluher M, Hermansen K, et al. Early responders to liraglutide 3.0 mg as adjunct to diet and exercise from the SCALE obesity and pre-diabetes trial: efficacy and safety results. Poster presented at: The 24th Annual Scientific & Clinical Congress of the American Association of Clinical Endocrinologists (AACE). May 13-17, 2015; Nashville, TN.
² Saxenda [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2015.
³ 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.
⁴ Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
⁵ Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
⁶ Saxenda [summary of product characteristics]. Bagsvaerd, Denmark:Novo Nordisk A/S; 2015.
⁷ Data on file. Novo Nordisk Inc Plainsboro, NJ.

Saxenda^® and Victoza^® are registered trademarks and SCALE is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2015 Novo Nordisk All rights reserved. 0415-00026579-1 May 2015

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SOURCE Novo Nordisk Inc.