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

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.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 that is 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 take Levemir if you are allergic to any of the ingredients in Levemir.

If you take 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 take Levemir.

Before you take 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 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.

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

References:

Children and Diabetes – More Information. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/diabetes/projects/cda2.htm. Accessed May 4, 2012.
Rewers A, Chase HP, Mackenzie T, et al. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002;287(19):2511–2518.
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.
American Diabetes Association. Standards of Medical Care in Diabetes – 2012: Position Statement. Diabetes Care. 2012;35(1):S11-S63.
SOURCE Novo Nordisk


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

Web Site: http://novonordisk-us.com

 

Posted: May 2012

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Levemir (insulin detemir ) FDA Approval History

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