FDA Approves Novo Nordisk’s Levemir Insulin for Pregnant Women with Diabetes

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The U.S. FDA has approved Novo Nordisk’s Levemir insulin (insulin detemir [rDNA origin] injection) for use by pregnant women with diabetes, giving it a Category B classification, indicating that it does not increase the risk of harm to the unborn baby.

The label update makes Levemir the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for pregnant woman with diabetes. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification.

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 HbA1c 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.

In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes.

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