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FDA Approves NovoLog(R) (Insulin Aspart [rDNA Origin] Injection) Category Change for Use in Pregnant Women with Type 1 Diabetes

New Category B Rating Follows Review of the Largest Randomized Controlled Trial of Insulin Analogs in Pregnant Women

PRINCETON, NJ -- January 30, 2007 -- 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<0.053)

-- Reduced risk of neonatal hypoglycemia (glucose <2.6 mmol/L) requiring treatment

-- Consistently low rates of major hypoglycemia

-- Reduced risks to the fetus, with outcomes at least comparable to HRI(2).

Diabetes and Pregnancy
Each year in the US, about 18,000 women with pre-existing type 1 or type 2 diabetes(3) become pregnant and 135,000 pregnant women develop gestational diabetes (those who develop high blood sugar during pregnancy(4)). For these pregnant women, insulin is frequently used to manage their diabetes(5).

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.

REFERENCES:
1. "Current Categories for Drug Use in Pregnancy," FDA (2006). http://www.fda.gov/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 http://www.cdc.gov/nccdphp/publications/factsheets/Prevention/diabetes.htm. Accessed November 8, 2006.
4. American Diabetes Association. Gestational Diabetes. Available at http://www.diabetes.org/gestational-diabetes.jsp. Accessed November 8, 2006.
5. "Diabetes in Pregnancy," March of Dimes (2006). http://www.marchofdimes.com/professionals/681_1197.asp
6. Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change with Proven Solutions, University Press," JAMA 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. http://www.cdc.gov/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 http://www.hms.harvard.edu/news/pressreleases/jos/0905bloodglucose.html
11. "Diabetes and Pregnancy," Organization of Teratology Services (2006). http://otispregnancy.org/pdf/diabetes.pdf
12. Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change with Proven Solutions, University Press," JAMA book review (9/27/2006).


SOURCE Novo Nordisk

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