Novo Nordisk announced that the FDA has approved NovoLog (insulin aspart [rDNA origin] injection) for pregnancy Category B rating. The move follows a review of the largest-ever randomized controlled trial using an insulin analog in pregnant women with type 1 diabetes.
The move up to Category B from Category C means that adequate studies in pregnant women have demonstrated that NovoLog does not increase risk to the unborn baby. The Category C rating indicated that adverse effects on animal fetuses had been found in studies, and that adequate trials in pregnant women had not yet been conducted to demonstrate safety.
Compared to human regular insulin (HRI), the study with NovoLog showed better outcomes for both mother and child by re-ducing the number of preterm deliveries, lowering risk of neonatal hypoglycemia requiring treatment, and producing consistently low rates of major hypoglycemia. Because it has a more rapid onset and shorter duration of action than HRI, NovoLog is normally used in combination with an intermediate or long-acting insulin.