Basal insulin approved for pregnant women
FDA approved the first and only basal insulin analog (Levemir, Novo Nordisk) for use in pregnant women, the company announced last week.
The label change assigned Novo Nordisk’s insulin detemir [rDNA origin] injection to a pregnancy Category B designation, indicating that the drug does not increase the risk of harm to the fetus, according to a PR Newswire release.
“We are excited that the FDA granted approval for this new category rating for Levemir,” said Lois Jovanovic, MD, MACE, chief scientific officer, Sansum Diabetes Research Institute in Santa Barbara, Calif., in the release. “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.”
The FDA category change was based on a review of a large, randomized controlled trial that examined insulin detemir in pregnant women with type 1 diabetes. The study compared the safety and efficacy of the drug compared with NPH (human insulin) in 310 women. The study demonstrated that patients taking insulin detemir had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. In addition, there was no difference in safety during pregnancy or on the health of the fetus and newborn.
For more information, visit www.levemir-us.com.