The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Levemir (insulin detemir [rDNA origin] injection) for a Pregnancy Category B classification, indicating that Levemir, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.
The label update makes Levemir the first basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy.
The FDA category change was based on a review of a large, randomized controlled trial examining Levemir in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir against NPH insulin in the treatment of 310 women. 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.
Release Date: April 2, 2012
Source: Novo Nordisk
Filed Under: Drug Discovery