FDA Approves NovoLog(R) (Insulin Aspart [rDNA Origin] Injection) for Treatment of Diabetes in Children |
| Novo Nordisk of North America logo. (PRNewsFoto)
NEW YORK, NY USA | |||
- Effective treatment now available for rising patient group -
PRINCETON, N.J., Sept. 15 /PRNewswire/ -- Novo Nordisk Inc. announced
today that the U.S. Food and Drug Administration (FDA) has approved the
supplemental new drug application (sNDA) of NovoLog(R) (insulin aspart [rDNA
origin] injection) for the treatment of diabetes in children. NovoLog(R) is a
rapid-acting insulin analogue which can be administered immediately before a
meal. The FDA approval comes approximately 4 months before the agency's
review deadline.
(Photo: http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO )
"The incidence of both type 1 and type 2 diabetes is increasing in
children," said Peter Aurup, M.D., Vice President of Clinical Development,
Medical, and Regulatory Affairs, Novo Nordisk Inc. "Approximately one in
every 400 to 500 children and adolescents has type 1 diabetes. The approval
of this new indication is a tremendous advance for the medical community who
treat diabetes in children. NovoLog is now recognized as a new, effective and
well tolerated option for these young patients," he added.
NovoLog was studied for use in children and adolescents with diabetes
ranging in age from two to 18. In these studies, NovoLog was found to be both
safe and effective.
About Diabetes in Children(1)
According to the American Diabetes Association, the risk of developing
type 1 diabetes is higher than virtually all other severe chronic diseases of
childhood. Peak incidence occurs during puberty. The symptoms of
type 1 diabetes can mimic the flu in children.
Additionally, a growing number of children and adolescents are developing
type 2 diabetes -- a form of diabetes that is generally diagnosed among
adults.
About NovoLog
NovoLog is a rapid acting form of insulin for the treatment of patients
with diabetes mellitus (type 1 and type 2) for the control of hyperglycemia.
It enters the bloodstream quickly and begins working within minutes to lower
blood glucose. The rapid onset and short duration of action mimic the insulin
action of a person without diabetes. NovoLog offers convenient mealtime
dosing and should be dosed immediately or up to 10 minutes before a meal.
NovoLog is available in the prefilled NovoLog FlexPen(TM) insulin delivery
system and is approved for use in insulin pumps.
NovoLog is contraindicated during episodes of hypoglycemia and in patients
hypersensitive to insulin aspart or one of its excipients. Hypoglycemia is the
most common adverse effect of insulin therapy, including NovoLog. See package
insert for more details.
NovoLog was originally approved by the FDA for use in adults in the U.S.
in 2000.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 80-year history of innovation
and achievement in diabetes care. With the broadest diabetes product
portfolio in the industry, including the most advanced products within the
area of insulin delivery systems, Novo Nordisk is a world leader in diabetes
care. In the United States, Novo Nordisk is working as a catalyst to improve
diabetes prevention and treatment; the company strives to be the preferred
partner for employees, patients, healthcare providers, and others in the
healthcare system who share its vision to defeat diabetes. In addition to
diabetes care, Novo Nordisk has a leading position within areas such as
hemostasis management, growth hormone therapy, and hormone therapy for women.
Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to
economic success, environmental soundness, and social responsibility to
employees and customers. With headquarters in Denmark, Novo Nordisk employs
approximately 21,000 full-time employees in 78 countries, and markets its
products in 179 countries. Novo Nordisk's B shares are listed on the stock
exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock
Exchange under the symbol 'NVO'. For global information, visit
http://www.novonordisk.com; for United States information, visit
http://www.novonordisk-us.com.
References:
1. Diabetes Statistics For Youth, American Diabetes Association Fact Sheet
SOURCE Novo Nordisk Inc.
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Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20020404/NVOLOGO
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Susan Jackson, media contact,
+1-609-919-7776, or Mads Veggerby Lausten, investor contact,
+1-609-919-7937, both for Novo Nordisk Inc.
