Insulin Analog Cleared for Use in Pumps by Pediatric Patients
The FDA has cleared NovoLog (insulin aspart [rDNA origin] injection) from Novo Nordisk for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients aged 4-18 years.
It is the first and only insulin analog approved for this use. Data from a trial published in Diabetes Care (2008;31:210-215) in support of the approval demonstrated that compared to insulin lispro CSII, NovoLog CSII achieved similar levels of glycemic efficacy and safety.
Results came from a 16-week, open-label, multicenter, parallel group study of 298 patients.