FDA APPROVES NOVO NORDISK'S NOVOLOG FOR PREGNANT WOMEN

Novo Nordisk announced that the 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.

Diabetes and its treatment options can present significant challenges for women wishing to conceive and have healthy pregnancies, according to the company. As a safety precaution, the FDA classifies prescription drugs with specific category ratings to provide decisionmaking 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 unborn babies.

Previously, NovoLog 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. The category change was based on an FDA review of the largest ever randomized, controlled trial using an insulin analog in pregnant women with Type 1 diabetes, according to Novo Nordisk.

The study, conducted at 63 sites in 18 countries, compared the safety and efficacy of NovoLog versus human regular insulin 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 and human regular insulin.