FDA Approves Levemir® Pregnancy Category Change for Women with Diabetes

Press Release

Levemir® is the first and only basal insulin analog with Pregnancy Category B classification

Princeton, N.J. (April 2, 2012) – Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved 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 and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. 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 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.

"It is exciting that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovič, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar.”

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[i].

Novo Nordisk now offers its comprehensive line of insulin analog products with a Pregnancy Category B classification for use with the FlexPen®, including Levemir® (insulin detemir [rDNA origin] injection) FlexPen®. FlexPen® is a discreet, prefilled insulin pen device that gives patients the ability to manage their diabetes while they’re on-the-go. FlexPen® is covered on more than 90 percent of insurance plans.

For more information, visit www.levemir-us.com.

Tags: FDA, insulin, pre-natal, safety

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