NovoRapid gets EC OK for pregnant diabetics

Danish drugmaker Novo Nordisk says that the European Commission has approved its rapid-acting insulin product NovoRapid (insulin aspart) for use by pregnant women with diabetes.

The approval follows a large-scale trial of the drug in 322 pregnant type 1 diabetes sufferers, which continued for four years. The results demonstrated that the drug significantly improved first and third trimester postprandial glycemic control, in comparison with human insulin treatment. The findings also revealed that the risk of major hypoglycemia was 28% lower for patients who received the Danish firm's product as opposed to human insulin therapy. Additionally, the likelihood of nocturnal and diurnal hypoglycemic events was reduced 52% and 15%, respectively.

The study, which was the largest ever examination of diabetes treatment in pregnant women in the European Union, also showed that NovoRapid was associated with fewer preterm deliveries (p<0.053), a lower risk of neonatal hypoglycemia and had a safety and tolerability profile that was comparable with the effects of standard human insulin therapy. The firm concluded that the drug brought about better treatment outcomes for mother and child.