FDA OKs pregnancy use of Novo Nordisk diabetes therapy Levemir

The US Food and Drug Administration has approved Levemir (insulin detemir [rDNA origin] injection), from Danish insulin giant Novo Nordisk (NOV: N) 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 company noted.

In the USA, there are around 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.