Novo Nordisk A/S Release: New Data In Adults With Obesity Or Who Are Overweight With Comorbidities Losing At Least 5% Body Weight With Saxenda (liraglutide [rDNA origin] injection) Showed Improvement In Blood Glucose, CV Risk Factors And Quality Of Life O

SAN DIEGO, March 7, 2015 /PRNewswire/ -- Today, new data from the phase 3a SCALE Obesity and Pre-diabetes trial were presented at The Endocrine Society’s 97^th Annual Meeting (ENDO), showing that adults with obesity or who are overweight with comorbidities who had lost 5% of their body weight at 56 weeks (i.e., weight loss responders), demonstrated greater improvements across a range of efficacy outcomes with Saxenda^® (liraglutide [rDNA origin] injection) treatment in combination with a reduced-calorie diet and increased physical activity, compared with those that had a weight loss of <5% (i.e., non-responders).¹

In the SCALE Obesity and Pre-diabetes trial, 63.2% of adults achieved a clinically meaningful body weight reduction of at least 5% with Saxenda^® compared with 27.1% on placebo (P<0.0001). The average weight loss for responders on Saxenda^® treatment was 11.7% compared with 1.7% for non-responders. For placebo treatment, average weight loss in responders was 10.0% versus 0.1% weight gain in non-responders. Saxenda^® treatment was associated with a greater reduction in waist circumference in responders, compared with non-responders (11.0 cm vs. 3.3 cm).¹

In addition to weight loss, improvements across a number of secondary endpoints were also observed in the responder population (Saxenda^® and placebo). A greater improvement was seen in fasting plasma glucose (FPG) in Saxenda^® responders compared with placebo responders (-8.3 vs. -2.8 mg/dl, respectively) as well as non-responders (-5.0 vs. +1.1 mg/dl, respectively). In addition, treatment with Saxenda^® was associated with a greater reduction in systolic blood pressure (SBP) compared with placebo in both responders (-5.5 vs. -3.4 mm Hg, respectively) and non-responders (-2.0 vs. -0.8 mm Hg, respectively). Improvements in physical health scores (as measured by the SF-36 questionnaire) were seen with Saxenda^® and placebo responders (+4.3 vs. +4.1 points, respectively) compared with non-responders (+2.1 vs. +1.3 points, respectively).¹

“These are important findings as they show that for adults with obesity or who are overweight with comorbidities, losing 5% to 10% of their body weight can help improve comorbidities, including fasting plasma glucose and blood pressure,” said Dr. Patrick O’Neil, Professor of Psychiatry and Behavioral Sciences at the Medical University of South Carolina and SCALE clinical trial investigator. “Those who responded, losing 5% or more of their body weight, not only saw improvements in cardiometabolic risk factors but also in quality of life outcomes, compared with those who did not respond, for both liraglutide and placebo treatment.”

Across the SCALE clinical development program, Saxenda^® (liraglutide [rDNA origin] injection) was generally well tolerated. The most common side effects observed were related to the gastrointestinal system.² In the SCALE Obesity and Pre-diabetes trial, rates of adverse events were similar in both responders and non-responders. The number of adverse events leading to trial withdrawal was lower in responders compared with non-responders.¹

Indications and Usage

• 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).

Limitations of Use

• Saxenda^® is not indicated for the treatment of type 2 diabetes.
• Saxenda^® should not be used in combination with any other GLP-1 receptor agonist.
• Saxenda^® should not be used with insulin.
• The effects of Saxenda^® on cardiovascular morbidity and mortality have not been established.
• The safety and efficacy of coadministration with other products for weight loss have not been established.
• Saxenda^® has not been studied in patients with a history of pancreatitis.

For full prescribing information, please go to www.Saxenda.com.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda^® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda^® (liraglutide [rDNA origin] injection) is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Saxenda^® and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda^®.

Contraindications
Saxenda^® is contraindicated in the following conditions:

• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components
• Pregnancy

Warnings and Precautions

• Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda^® observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda^® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda^® should not be restarted.
• Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Saxenda^®-treated patients than in placebo-treated patients even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
• Serious Hypoglycemia: When Saxenda^® is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.
• Heart Rate Increase: For patients who experience a sustained increase in resting heart rate while taking Saxenda^®, Saxenda^® should be discontinued.
• Renal Impairment: Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda^® in patients with renal impairment.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda^® and promptly seek medical advice.
• Suicidal Behavior and Ideation: Patients treated with Saxenda^® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda^® in patients who experience suicidal thoughts or behaviors. Avoid Saxenda^® in patients with a history of suicidal attempts or active suicidal ideation.

Adverse Events

• The most common adverse reactions, reporting in 5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Use in Specific Populations

• Nursing mothers should either discontinue Saxenda^® (liraglutide [rDNA origin] injection) or discontinue nursing.
• Safety and effectiveness of Saxenda^® have not been established in pediatric patients and is not recommended for use in pediatric patients.

About obesity
Obesity is a disease that requires chronic management.^3-5 It is associated with serious comorbidities including type 2 diabetes, heart disease, obstructive sleep apnea (OSA), certain types of cancer and a decreased life expectancy.^6-8 The risk of morbidity and mortality increases with the severity of obesity.^8,9 It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors.¹⁰

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.^11,12 In 2011-2012 in the U.S., approximately 35% of adults, or nearly 80 million adults, lived with obesity.¹³

About Saxenda^®
Saxenda^® is a once-daily glucagon-like peptide-1 (GLP-1) analog with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.² 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 comorbidities.²

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 30 kg/m²) or who are overweight (BMI 27 kg/m²) with at least one weight-related comorbidity.¹⁴

Saxenda^® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on January 22, 2015. In accordance with the EMA Centralised Procedure, a decision whether to grant marketing authorization is taken by the European Commission within approximately 2 to 3 months.¹⁴

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 comorbidities. There were 3,731 participants randomized to treatment with Saxenda^® (liraglutide [rDNA origin] injection) 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.¹⁴

The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks, 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.¹⁵

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 comorbidities.¹⁴

About Novo Nordisk
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 hemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

References

SCALE is a trademark of Novo Nordisk A/S.
Saxenda^® is a registered trademark of Novo Nordisk A/S.
© 2015 Novo Nordisk All rights reserved. 0215-00025317-1 March 2015

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-data-in-adults-with-obesity-or-who-are-overweight-with-comorbidities-losing-at-least-5-body-weight-with-saxenda-liraglutide-rdna-origin-injection-showed-improvement-in-blood-glucose-cv-risk-factors-and-quality-of-life-o-300047002.html

SOURCE Novo Nordisk Inc.