Healthcare major Novo Nordisk Friday said the European Commission (EC) had approved its rapid-acting insulin NovoRapid for use by pregnant women with diabetes.
According to a company statement here, the EC approval follows results of the random trials of modern insulin in pregnant women with type 1 diabetes.
"NovoRapid is the first modern insulin that can be used in pregnancy in the European Union. The trial, which involved 322 pregnant women with type 1 diabetes and lasted four years, revealed the insulin improves first and third trimesters post-prandial glycaemic control as compared to human insulin," the statement said.
Diabetes presents a major problem for many women wishing to conceive. Population studies show babies of women with type 1 diabetes continue to have a higher risk of prenatal death and congenital anomalies than general population.
Compared to human insulin, the trial with NovoRapid showed improved outcome for both mother and child in terms of fewer premature deliveries, reduced risk of neo-natal hypoglycaemia requiring treatment and reduced risks to the foetus.
Novo Nordisk claims to have the largest diabetes product portfolio in the industry, including the most advanced insulin delivery systems. The Danish company manufactures as well as markets pharmaceutical products and services.