The U.S. Food and Drug Administration (FDA) has just approved Levemir®, an insulin detemir [rDNA origin] injection, as the first and only basal insulin analog for Pregnancy Category B classification, which indicates that Levemir® does not pose a higher risk of harm for the unborn when used in pregnant women with diabetes. The drug is manufactured by Novo Nordisk.
Until now, the standard of care for diabetes in pregnancy has consisted of NPH, i.e. human insulin, however this has now changed, with Novo Nordisk being the only company that is able to provide a complete portfolio of insulin analogs with Pregnancy Category B classification.
FDA approval was granted following a review of a large, randomized controlled trial that involved 310 pregnant women with type 1 diabetes, which assessed Levemir's® safety and efficacy compared with NPH insulin. The results demonstrated that women who were administered with Levemir® had a comparable reduction in A1C at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 than women who received NPH. The researchers noted no difference in results regarding Levemir's® overall safety profile during pregnancy, its outcomes or the health of the fetus and newborn.
Lois Jovanovič, MD, MACE, Chief Scientific Officer at Sansum Diabetes Research Institute in Santa Barbara, California remarked:
"It is exciting that the FDA has granted approval for this new category rating for Levemir®. 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."
About 1.85 million women of childbearing age in the U.S. suffer from diabetes. Levemir® offers a new alternative therapy for those who wish to start a family.
Including Levemir®, Novo Nordisk's now offers a complete range of insulin analog products with Pregnancy Category B classification for use with the FlexPen®, a discreet, prefilled insulin pen that enables patients to manage their diabetes anywhere, anytime and is covered by over 90% of insurance plans cover the FlexPen®.
Levemir® (insulin detemir [rDNA origin] injection) Indications and Usage:
Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting insulin, which is designed to control high blood sugar in adults and children with diabetes mellitus. It is not recommended for use in individuals with diabetic ketoacidosis.
Important Safety Information:
Levemir® should not be taken if any of its ingredients could cause an allergic reaction.
If the dosage of Levemir® has been exceeded, it may lead to hypoglycemia (abnormally low blood sugar levels). Check blood sugar levels and consult your health care provider what your blood sugar levels should be and when they should be checked. Alcohol consumption can affect blood sugar levels when taking Levemir®.
Health care providers should be fully informed about all medicines taken, all medical conditions, including liver or kidney problems as well as pregnancy or breastfeeding or plans of starting a family before Levemir® is taken.
Click here for Levemir® complete Prescribing Information.
Written by Petra Rattue