NOVO NORDISK
Mon, 17 Jun 2019 17:41:00 -0400
Mon, 17 Jun 2019 17:41:00 -0400
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:
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:
Who should not use Victoza®?
Do not use Victoza® if:
What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:
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®?
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
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
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