FDA Approves NovoLog(R) (Insulin Aspart [rDNA Origin] Injection) for Treatment of Diabetes in Children

- Effective treatment now available for rising patient group -



Sep 16, 2005, 01:00 ET from Novo Nordisk Inc.

    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.
    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.