FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years

PLAINSBORO, N.J., June 17, 2019 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza^® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. As the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, Victoza^® provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years. Victoza^® was first approved in the U.S. in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The update is based on results from the global ELLIPSE trial, the first phase 3 trial completed in over a decade in children and adolescents with type 2 diabetes. In this study, patients aged 10 to 17 were randomized to receive liraglutide up to 1.8 mg/day or placebo, in combination with metformin with or without basal insulin over a 26-week double-blinded period followed by a 26-week open-label extension period.¹

"We are delighted with the label expansion for Victoza^®, which now includes an indication for use in children and adolescents with type 2 diabetes in the U.S. - this is a landmark approval as the first-ever GLP-1 receptor agonist approved for this population," commented Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The prevalence of type 2 diabetes in the U.S. is ever increasing and we are seeing a higher number of diagnoses in children and adolescents, for whom there are limited treatment choices. Victoza^® will provide a new option for clinicians treating this challenging disease, helping to address the growing need for this population."

According to the World Health Organization, type 2 diabetes is becoming increasingly more common in children and young adults. However, because the disease often goes undiagnosed and studies to assess the number of newly occurring cases are complicated, there is very little data on its true incidence.² In the U.S., it is estimated that type 2 diabetes accounts for approximately half of all new cases of diabetes in adolescents and a third of these cases are undiagnosed.³

Indications and Usage

What is Victoza^®?
Victoza^® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Victoza^® is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Victoza^® can be used with mealtime insulin.
It is not known if Victoza^® is safe and effective to lower blood sugar in children under 10 years of age.

Important Safety Information

What is the most important information I should know about Victoza^®?
Victoza^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your health care 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. In studies with rats and mice, Victoza^® and medicines that work like Victoza^® caused thyroid tumors, including thyroid cancer. It is not known if Victoza^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza^®?
Do not use Victoza^® 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).
• you are allergic to liraglutide or any of the ingredients in Victoza^®.

What should I tell my health care provider before using Victoza^®?
Before using Victoza^®, tell your health care provider if you:

• have or have had problems with your pancreas, kidneys, or liver.
• have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza^®?

• Do not mix insulin and Victoza^® together in the same injection.
• You may give an injection of Victoza^® and insulin in the same body area (such as your stomach area), but not right next to each other.
• Do not share your Victoza^® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

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

• inflammation of your pancreas (pancreatitis). Stop using Victoza^® and call your health care 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.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Victoza^® regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
• serious allergic reactions. Stop using Victoza^® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
• gallbladder problems. Gallbladder problems have happened in some people who take Victoza^®. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turns yellow.

The most common side effects of Victoza^® may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Please click here for Prescribing Information and Medication Guide.

About Victoza^®
Victoza^® (liraglutide) injection is a human glucagon-like peptide-1 (GLP-1) receptor agonist that is approved by the U.S. Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.¹ Victoza^® is commercially available in more than 100 countries, treating more than 1.2 million people with type 2 diabetes globally.

About ELLIPSE
ELLIPSE (NCT01541215) is a phase 3, randomized, placebo-controlled, parallel group, multinational trial in which 135 children and adolescents 10-17 years of age were randomized 1:1 to treatment with Victoza^® (liraglutide) injection up to 1.8 mg/day or placebo, in combination with metformin, with or without basal insulin, and diet and exercise for a 26-week, double-blind period, followed by a 26-week open label extension (total 52 weeks).¹

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.

References

1. Tamborlane WV, Barrientos-Perez M, Fainberg U, et al. Liraglutide in Children and Adolescents with Type 2 Diabetes. New England Journal of Medicine. 2019.
2. World Health Organization. Global Report on Diabetes. Available at: http://apps.who.int/iris/bitstream/10665/204871/1/9789241565257_eng.pdf Last accessed: May 2019.
3. Demmer RT, Zuk AM, Rosenbaum M, et al. Prevalence of diagnosed and undiagnosed type 2 diabetes mellitus among US adolescents: results from the continuous NHANES, 1999-2010. American Journal of Epidemiology. 2013;178:1106-1113.

Victoza^® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.

© 2019 Novo Nordisk         All rights reserved.      US19VZ00058           June 2019

SOURCE Novo Nordisk