Novo Nordisk A/S Announces Saxenda (Liraglutide [Rdna Origin] Injection) Is Now Commercially Available In The United States

PLAINSBORO, N.J., April 22, 2015 /PRNewswire/ -- Novo Nordisk today announced that Saxenda^® (liraglutide [rDNA origin] injection) is now available in the United States. Saxenda^® is the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults. It is indicated in the United States 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) in the presence of at least one weight-related comorbid condition.

Recently recognized as a disease by the American Medical Association and other medical societies, obesity has grown in prevalence in the United States and around the world.^1-5  In fact, approximately 35% of the U.S. adult population lived with obesity in 2011 to 2012.^6,7

"Novo Nordisk is pleased to offer a new treatment that can provide some patients who have obesity or are overweight with comorbidities a new path to achieving clinically meaningful weight loss," said Jesper Hoiland, President of Novo Nordisk Inc. "We believe the launch of Saxenda^® represents a significant contribution to the therapeutic options that are advancing obesity care. For Novo Nordisk, it also aligns with our long-term commitment to help patients with chronic disease."

Saxenda^® was evaluated in the SCALE (Satiety and Clinical AdiposityLiraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical 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. Trial data showed that Saxenda^®, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss in some patients than reduced-calorie diet and physical activity alone.⁸

"Diet and increased physical activity are important and should be part of any weight-loss program; however, for some people with obesity a pharmacotherapy treatment option like Saxenda^® may be needed  to help them with chronic weight management," said Dr. Ken Fujioka, Department of Nutrition and Metabolic Research, Scripps Clinic, La Jolla, California, and a SCALE clinical trial investigator.

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^® (liraglutide [rDNA origin] injection) is not indicated for the treatment of type 2 diabetes.
• Saxenda^® and Victoza^® both contain the same active ingredient, liraglutide, and therefore should not be used together.
• Saxenda^® has not been studied in patients taking insulin. Saxenda^® and insulin should not be used together.
• The effects of Saxenda^® on cardiovascular morbidity and mortality have not been established.
• The safety and efficacy of Saxenda^® in combination with other products for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Saxenda^® has not been studied in patients with a history of pancreatitis.

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^® 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

• Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
• 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^® (liraglutide [rDNA origin] injection) 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.
• Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: 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. Monitor blood glucose parameters prior to starting Saxenda^® and during Saxenda^® treatment in patients with type 2 diabetes mellitus.
• Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in Saxenda^®-treated patients compared to placebo in clinical trials. Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Saxenda^® treatment. For patients who experience a sustained increase in resting heart rate while taking Saxenda^®, Saxenda^® should be discontinued.
• Renal Impairment: In patients treated with GLP-1 receptor agonists, including Saxenda^®, there have been reports of acute renal failure and worsening of chronic renal failure, 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: In the Saxenda^® clinical trials, 6 (0.2%) of 3,384 Saxenda^®-treated patients and none of the 1,941 placebo-treated patients reported suicidal ideation; one of the Saxenda^®-treated patients attempted suicide. 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, reported in >5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Drug Interactions

• Oral Medications: Saxenda^® causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda^®.

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.
• Saxenda^® slows gastric emptying. Saxenda^® has not been studied in patients with preexisting gastroparesis.

About obesity                                                                                                             
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems.^4,5 In 2011 to 2012 in the United States, approximately 35% of adults, or nearly 80 million adults, lived with obesity.⁶

About Saxenda^®
Saxenda^® is a once-daily glucagon-like peptide-1 (GLP-1) receptor analog 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.⁸

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.⁹

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 haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com,Facebook, Twitter, LinkedIn, YouTube.

References

¹ American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed September 8, 2014.
² 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.
³ Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25_PA):2985-3023.
⁴ 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.
⁵ Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
⁶ 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.
⁷ Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of comorbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(88):1471-2458. 
⁸ Saxenda [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 
⁹ Data on file. Novo Nordisk Inc Plainsboro, NJ.

Saxenda^® is a registered trademark and SCALE^TM is a trademark of Novo Nordisk A/S.
© 2015 Novo Nordisk   All rights reserved.   0315-00025949-1   April 2015

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SOURCE Novo Nordisk Inc.