FDA Approves NovoLog(R) Category Change For Use In Pregnant Women With Type 1 Diabetes

Novo Nordisk announced today
that the United States Food and Drug Administration (FDA) has approved
NovoLog(R) (insulin aspart [rDNA origin] injection) for pregnancy Category
B rating, further validating NovoLog(R) as a safe and effective treatment
for pregnant women with Type 1 diabetes and their unborn children.



Diabetes and its treatment options can present significant challenges
for women wishing to conceive and have a healthy pregnancy. As a safety
precaution, the FDA classifies prescription drugs with specific category
ratings to provide decision-making guidelines for physicians treating
pregnant women. The Pregnancy Category B rating for NovoLog(R) indicates
that adequate studies in pregnant women with Type 1 diabetes have
demonstrated that NovoLog(R) does not increase risk to the unborn baby.
Previously, NovoLog(R) was classified as a Category C rating, which
indicates that adverse effects on the fetus have been demonstrated in
animal reproduction studies, and that adequate and well-controlled studies
in pregnant women have not been conducted to demonstrate safety(1).



"While clinical research is rarely conducted in pregnant women, we at
Novo Nordisk understand the needs of this special population. The confirmed
safety of NovoLog(R) will allow their doctors to make informed decisions
about treatment options for people with diabetes," said Martin Soeters,
president of Novo Nordisk. "We are excited that the FDA has acknowledged
our efforts to advance diabetes treatment and recognizes the value of our
insulin analogs such as NovoLog(R)."



The FDA category change was based on a review of the largest ever
randomized controlled trial using an insulin analog in pregnant women with
type 1 diabetes.



The study, conducted at 63 sites in 18 countries, compared the safety
and efficacy of NovoLog(R) versus human regular insulin (HRI) in the
treatment of 322 pregnant women with type 1 diabetes. Data demonstrated
that changes in HbA1c and rates of maternal hypoglycemia were comparable
with NovoLog(R) compared to HRI. The study was not large enough to evaluate
the risk of congenital malformations. Compared to HRI, the trial with
NovoLog(R) showed improved outcomes for both mother and child in terms of:


-- Fewer preterm deliveries (p








Diabetes that is not tightly controlled can lead to extensive
complications for mother and baby and can cause significant burdens on
families and the healthcare system(6):


-- For the mother, complications from existing diabetes may worsen and new
complications may emerge(7), including greater incidence of
miscarriage, high blood pressure, kidney disease and nerve
damage(8).


-- For the baby, uncontrolled diabetes may mean up to four-times more
likelihood of being born with increased infant mortality, preterm birth
(and the myriad of problems associated with it), high birth weight(9)
or a birth defect(10).



Chances of these complications are lower when women have good glycemic
control(11). However, only 40-60 percent of women with pre-existing
diabetes achieve optimal glycemic control while pregnant(12).



About NovoLog(R)



NovoLog(R) is a rapid-acting form of insulin for the treatment of
people with diabetes mellitus 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(R) offers convenient mealtime
dosing and should be administered before a meal (start of meal within 5 to
10 minutes after injection). NovoLog is available in the prefilled
NovoLog(R) FlexPen(R) insulin delivery system.



NovoLog(R) is contraindicated during episodes of hypoglycemia and in
people hypersensitive to insulin aspart or one of its excipients.
Hypoglycemia is the most common adverse effect of insulin therapy,
including NovoLog(R). See package insert for more details. NovoLog(R) was
originally approved by the FDA for use in adults in the U.S. in 2000.



Because it has a more rapid onset and shorter duration of action than
regular human insulin, NovoLog(R) should normally be used in regimens
together with an intermediate or long-acting insulin, and injection of
NovoLog(R) should immediately be followed by a meal.



Any change in insulin should be made cautiously and only under medical
supervision.



Prescribing information for NovoLog is available by contacting Novo
Nordisk or by visiting novonordisk-us.



Novo Nordisk is a healthcare company with an 80-year history of
innovation and achievement in diabetes care. 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
more than 23,000 employees in 79 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 novonordisk; for
United States information, visit novonordisk-us.


References



(1) "Current Categories for Drug Use in Pregnancy," FDA (2006).
fda/fdac/features/2001/301_preg.html#categories



(2) Data on file at Novo Nordisk Inc.



(3) Centers for Disease Control and Prevention. Preventing Diabetes and
Its Complications. Available at
cdc/nccdphp/publications/factsheets/Prevention/diabetes.htm.
Accessed November 8, 2006.



(4) American Diabetes Association. Gestational Diabetes. Available at
diabetes/gestational-diabetes.jsp. Accessed November 8,
2006.



(5) "Diabetes in Pregnancy," March of Dimes (2006).
marchofdimes/professionals/681_1197.asp



(6) Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change with
Proven Solutions, University Press," Journal of the American Medical
Association book review (9/27/2006).



(7) "Pregnancy and Diabetes Frequently Asked Questions," Centers for
Disease Control (2006).



(8) "Diabetes and Pregnancy Frequently Asked Questions," (2006),
Centers for Disease Control.
cdc/ncbddd/bd/diabetespregnancyfaqs.htm



(9) Ibid.



(10) "High Blood Glucose Levels in Early Pregnancy May Deprive Embryo
of Oxygen and Lead to Birth Defects, Joslin Diabetes Center Study Shows,"
(2005) Joslin Diabetes Center



(11) "Diabetes and Pregnancy," Organization of Teratology Services
(2006). otispregnancy/pdf/diabetes.pdf



(12) Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change
with Proven Solutions, University Press," Journal of the American Medical
Association book review (9/27/2006).


Novo Nordisk

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