The US Food and Drug Administration (FDA) has approved Novo Nordisk's Levemir (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification.
The approval indicates that Levemir, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.
The lable update makes Levemir the first basal insulin analog to have this classification, the company said.
The FDA category change was based on a review of a study which reported that patients taking Levemir had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH.
The study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.
