FDA Approves Levemir® for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes

Levemir® Is Now the First and Only Basal Insulin Analog Approved for Use in Patients as Young as Two

Princeton, N.J. (May 22, 2012) /PRNewswire/ — Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for use in children ages two to five years with type 1 diabetes. With the expansion of its pediatric indication, Levemir® is now available for type 1 diabetes patients from age two through adulthood and adult patients with type 2 diabetes.

The FDA approval now makes Levemir® the first and only basal insulin analog for use in this young patient group.

“Our biggest challenges and top priorities when treating some of the youngest children with type 1 diabetes are safety and reducing the risk of hypoglycemia,” said Dr. Mark Sperling, MD, Editor-in-Chief of Pediatric Diabetes. “Levemir®, with its approval from the FDA, is a particularly welcome addition to our treatment options for some of our youngest patients with type 1 diabetes.”

Each year, more than 13,000 young people are diagnosed with type 1 diabetes.¹ The youngest of these children with type 1 diabetes have the greatest likelihood of severe hypoglycemia and the highest risk of acute diabetes complications.²

The FDA decision was based on data that showed that Levemir® is an equally efficacious treatment option for two- to five-year-old children (n=82) with type 1 diabetes, compared with Neutral Protamine Hagedorn (NPH) insulin. Mean HbA1c was similar between groups (Levemir® 8.2% vs. NPH 8.1% at baseline, and 8.1% vs. 8.3%, respectively, at one year).³ According to 2012 American Diabetes Association guidelines, it is recommended that children younger than age six have an A1c goal of less than 8.5 percent.4

This pre-specified and stratified subgroup data showed that children with type 1 diabetes from ages two to five who received Levemir® plus a rapid-acting insulin analog, NovoLog® (insulin aspart [rDNA origin] injection), experienced a low rate of hypoglycemia compared with those taking NPH and NovoLog® (24-hour: 50.6 vs. 78.3 episodes per patient year).³ No patients treated with Levemir® had a severe hypoglycemic episode, whereas there were six reported episodes in three patients treated with NPH over the one year study period.³

In the study, a slightly lower proportion of patients receiving Levemir® reported adverse events than those receiving NPH (69.0% vs. 77.5%); the majority was considered unlikely related to the trial product. The most common severe adverse events (Levemir® group: 12%, NPH group: 15%) were infections (gastroenteritis) and gastrointestinal disorders (dyspepsia) in both treatment groups.³

In September 2011, the European Committee for Medicinal Products for Human Use (CHMP) similarly adopted a positive opinion on the extended use of Levemir® in children ages two to five years with type 1 diabetes.

For more information, visit www.levemir-us.com.

About Levemir® (insulin detemir [rDNA origin] injection)

Indications and Usage
Levemir® is a man-made long-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

It is not recommended to use Levemir® to treat diabetic ketoacidosis.

Important Safety Information:
Do not use Levemir® if you are allergic to any of the ingredients in Levemir®

If you use too much Levemir®, your blood sugar may fall too low (hypoglycemia). Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them. Drinking alcohol may affect your blood sugar when you use Levemir®

Before you use Levemir®, tell your health care provider about all of the medicines you take, and all of your medical conditions, including if you have liver or kidney problems, or if you are pregnant or breastfeeding or if you are planning to do so.

Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider.

Do not dilute or mix Levemir® with any other insulin or injectable diabetes medicine. Give yourself separate injections. You may give the injections in the same body area (for example, your stomach area), but you should not give them right next to each other. Do not use Levemir® in an insulin pump. Inject Levemir® under your skin (subcutaneously) in your upper arm, abdomen (stomach area) or thigh. Never inject Levemir® into a vein or muscle.

Do not share needles, insulin pens or syringes with others.

If you use Levemir® with another diabetes medicine, your Levemir® dose may need to be changed to reduce your chance of getting low blood sugar.

Common side effects of Levemir® include low blood sugar (hypoglycemia), local allergic reactions at the injection site (redness, swelling and itching), and weight gain. Serious side effects include low blood sugar (hypoglycemia), skin thickening or pits at the injection site (lipodystrophy), and allergic reactions. Serious allergic reactions can cause life-threatening symptoms. Get medical help right away if you have any symptoms of an allergic reaction such as body rash, itching, shortness of breath or wheezing, fast heartbeat, sweating, or feel faint. Ask your health care provider or pharmacist for more information.

Please see www.levemir-us.com for Levemir® complete Prescribing Information.

About NovoLog® (insulin aspart [rDNA origin] injection)

Indications and Usage
NovoLog® is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information
Do not take NovoLog® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in NovoLog®. If you take too much NovoLog® your blood sugar may fall too low.

NovoLog® is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog® to avoid low blood sugar. Do not inject NovoLog® if you do not plan to eat right after using NovoLog®. Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Do not mix NovoLog® with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe.

Needles and NovoLog® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your NovoLog® dose may change if you take other medicines.

NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.

The most common side effect of NovoLog® is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

Please see www.novolog.com for NovoLog® complete Prescribing Information.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk-us.com.

About Diabetes
In the United States, 25.8 million people have diabetes, a condition in which the body does not produce enough or properly use insulin, the hormone needed to convert sugar, starches and other food into energy needed for daily life.

For further information please contact:

Media: Investors:
   
In North America:  
Havilah Clarke Jannick Lindegaard
Tel: (+1) 609 786 4379 Tel: (+1) 609 786 4575
hvck@novonordisk.com jlis@novonordisk.com
   
In Europe:  
Katrine Sperling Kasper Roseeuw Poulsen
Tel: (+45) 4442 6718 Tel: (+45) 4442 4303
krsp@novonordisk.com krop@novonordisk.com

Levemir®, NovoLog® and FlexPen® are registered trademarks of Novo Nordisk A/S.

References:

  1. Children and Diabetes – More Information. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/diabetes/projects/cda2.htm. Accessed May 4, 2012.
  2. Rewers A, Chase HP, Mackenzie T, et al. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002;287(19):2511–2518.
  3. Thalange N, Bereket A, Larsen J, et al. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Ped Diabetes. 2011;12:632-641.
  4. American Diabetes Association. Standards of Medical Care in Diabetes – 2012: Position Statement. Diabetes Care. 2012;35(1):S11-S63.

© 2012 Novo Nordisk All rights reserved. 0512-00009369-1 May 2012

 

Novo Nordisk Announced the FDA has approved Levemir® for use in children as young as two with type 1 diabetes
Novo Nordisk Announced the FDA has approved Levemir® for use in children as young as two with type 1 diabetes

Related Links

www.novonordisk-us.com
www.levemir-us.com