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Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes
Tresiba® is the only long-acting insulin approved for use in people with type 1 and type 2 diabetes as young as age one

PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1 making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1

"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily."

Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1

Once-daily Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) is available in Novo Nordisk's latest insulin delivery device – FlexTouch® – as a 100 units/mL or 200 units/mL pen. Tresiba® U-100 FlexTouch® can deliver up to 80 units of insulin in a single injection. Tresiba® U-200 FlexTouch® can dose up to 160 units in a single injection. FlexTouch® is also the only prefilled insulin pen with no push-button extension.1

Eligible patients with commercial insurance can use the Tresiba® Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Eligibility and other restrictions apply. For complete terms and conditions and any questions regarding eligibility, visit https://www.tresiba.com/instant-savings-card/eligibility.html or call 1-855-834-3466.

Indications and Usage

Tresiba® is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®.

What is Tresiba®?

  • Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
  • Tresiba® is not for people with diabetic ketoacidosis
  • Tresiba® is not for children who need less than 5 units of Tresiba® each day
  • It is not known if Tresiba® is safe and effective in children under 1 year of age
  • Tresiba® is available in 2 concentrations: 200 units/mL and 100 units/mL

Important Safety Information

Do not share your Tresiba® FlexTouch® 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.

Who should not take Tresiba®?
Do not take Tresiba® if you:

  • are having an episode of low blood sugar
  • are allergic to Tresiba® or any of the ingredients in Tresiba®

Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are:

  • pregnant, planning to become pregnant, or are breastfeeding
  • taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL)?

  • Read the Instructions for Use and take Tresiba® exactly as your health care provider tells you to
  • Do not do any conversion of your dose. The dose counter always shows the selected dose in units
  • Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
  • Adults - If you miss or are delayed in taking your dose of Tresiba®:
    • Take your dose as soon as you remember, then continue with your regular dosing schedule
    • Make sure there are at least 8 hours between doses
  • If children miss a dose of Tresiba®:
    • Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of Tresiba®
  • Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
  • Do not reuse or share your needles with other people. You may give them a serious infection, or get a serious infection from them
  • Never inject Tresiba® into a vein or muscle
  • Never use a syringe to remove Tresiba® from the FlexTouch® pen

What should I avoid while taking Tresiba®?

  • Do not drive or operate heavy machinery, until you know how Tresiba® affects you
  • Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol

What are the possible side effects of Tresiba®?
Tresiba® may cause serious side effects that can be life-threatening, including:

  • Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache
  • Low potassium in your blood (hypokalemia)
  • Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Tresiba®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.

Common side effects may include reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please click here for Prescribing Information.

For more information about Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), please visit Media.Tresiba.com.  

About Diabetes
In the United States, more than 29 million people are affected by diabetes.4 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.4 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has almost quadrupled over the past 30 years.5

About Novo Nordisk
Novo Nordisk is a global health care 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: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

References

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
  2. American Diabetes Association. Statistics About Diabetes. http://www.diabetes.org/ diabetes- basics/statistics. ADA website. Accessed December 5, 2016. 
  3. Thalange N, Deeb L, Lotova V, et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatric Diabetes. 2015; 164-176.
  4. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. CDC website. Accessed December 5, 2016.
  5. Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 1980–2014. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. CDC website. Accessed December 5, 2016.

FlexTouch®, Levemir®, and Tresiba® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2016 Novo Nordisk     All rights reserved.     USA16TSM04519    December 2016

 Novo Nordisk, Inc.

 

SOURCE Novo Nordisk

For further information: Media - Katrine Sperling, +45 4442 6718, krsp@novonordisk.com, or Michael Bachner (U.S.), +1 609 664 7308, mzyb@novonordisk.com; or Investors - Peter Hugreffe Ankersen, +45 3075 9085, phak@novonordisk.com, or Melanie Raouzeos, +45 3075 3479, mrz@novonordisk.com, or Hanna Ögren, +45 3079 8519, haoe@novonordisk.com, or Anders Mikkelsen, +45 3079 4461, armk@novonordisk.com, or Kasper Veje (U.S.), +1 609 235 8567, kpvj@novonordisk.com
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