FDA approves pregnancy category change for insulin detemir injection

April 20, 2012

FDA has approved insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) pregnancy Category B classification, indicating that when used in pregnant women with diabetes, the injection did not increase the risk of harm to the unborn baby.

FDA has approved insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) pregnancy Category B classification. The new classification indicates that Levemir, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.

Previously, Levemir was relegated to pregnancy category C, meaning animal reproductive studies have shown an adverse effect on the fetus and adequate and well-controlled studies in humans were not available.

According to Novo Nordisk, Levemir is the only basal insulin analog to achieve the category B classification. “This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar,” said Lois Jovanovic, MD, chief science officer for the Sansum Diabetes Research Institute in Santa Barbara, Calif.

FDA changed Levemir’s status after receiving a new randomized, controlled trial of 310 pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir against NPH insulin and 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.

“The study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes, or the health of the fetus and newborn,” according to a statement from Novo Nordisk.

To view the new labeling and packaging insert, click here.