Levemir Pregnancy Category Change
Novo Nordisk announced that the FDA has approved Levemir (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that when used in pregnant women with diabetes, Levemir does not increase the risk of harm to the unborn baby. The new label update makes Levemir the first and only basal insulin analog to have this classification. NPH (human insulin) was considered the standard of care for diabetes in pregnancy up until this decision.
The FDA category change was based on a review of a large, randomized controlled trial examining the safety and efficacy of Levemir in 310 pregnant women with type 1 diabetes against NPH insulin. The study found 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. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.
Levemir is a man-made long-acting insulin indicated to treat type 1 diabetes (in adults and children) and type 2 diabetes (in adults) when basal insulin is needed.
For more information call (800) 727-6500 or visit www.levemir-us.com.