Novo Nordisk’s NovoLog OK in Pregnancy

Novo Nordisk said Tuesday the U.S. Food and Drug Administration approved its insulin analog NovoLog for pregnant women with diabetes.

The FDA changed the category rating of NovoLog from Category C to Category B, which indicates the drug is safe for an unborn baby.

The confirmed safety of NovoLog will allow their doctors to make informed decisions about treatment options for people with diabetes, said Martin Soeters, president of Novo Nordisk.

The category change was based on a study comparing the safety and efficacy of NovoLog versus human regular insulin in 322 pregnant women with type 1 diabetes.

The study was not large enough to examine the possibility of congenital malformations, but it found that women who received NovoLog had fewer preterm deliveries, reduced risk of neonatal hypoglycemia requiring treatment and reduced risks to the fetus.