NovoLog gets approval from FDA for pediatric use

PRINCETON, N.J. Novo Nordisk has received approval from the Food and Drug Administration for its insulin drug NovoLog to be used in external, subcutaneous insulin pumps by children and adolescents aged 4 to 18.

The approval came in large part due to a study Novo conducted comparing the drug to Eli Lilly’s insulin drug Humalog. That study was published in the February issue of Diabetes Care.

Some of the results of the study were: Nearly 60 percent of NovoLog patients versus 43.8 percent of Humalog patients achieved age-specific A1C goals and rates of hypoglycemia and numbers and types of adverse events were similar between both treatment groups.

“The approval of NovoLog in insulin pumps for the pediatric population highlights the safety and efficacy of NovoLog and underscores Novo Nordisk’s commitment to providing treatments that benefits this sometimes overlooked segment of the diabetes population,” said Alan C. Moses, vice president, chief medical officer worldwide.