Novo Nordisk announced that the United States Food and Drug Administration (FDA) has approved NovoLog (insulin aspart [rDNA origin] injection) for pregnancy Category B rating, further validating NovoLog 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 indicates that adequate studies in pregnant women with type 1 diabetes have demonstrated that NovoLog does not increase risk to the unborn baby. Previously, NovoLog was classified as a Category C rating, which indicates that adverse effects on the foetus have been demonstrated in animal reproduction studies, and that adequate and well-controlled studies in pregnant women have not been conducted to demonstrate safety.
"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 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."
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 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 hypoglycaemia were comparable with NovoLog compared to HRI. The study was not large enough to evaluate the risk of congenital malformations. Compared to HRI, the trial with NovoLog showed improved outcomes for both mother and child in terms of: Fewer preterm deliveries (p<0.053); Reduced risk of neonatal hypoglycaemia (glucose <2.6 mmol/L ) requiring treatment; Consistently low rates of major hypoglycaemia; Reduced risks to the fetus, with outcomes at least comparable to HRI.
NovoLog 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 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 FlexPen insulin delivery system.
NovoLog is contraindicated during episodes of hypoglycaemia and in people hypersensitive to insulin aspart or one of its excipients. Hypoglycaemia is the most common adverse effect of insulin therapy, including NovoLog.