EU OKs two new indications for Novo Nordisk's Levemir

There was good news for Danish insulin giant Novo Nordisk (NVO: N) yesterday, when the European Commission approved the extended use of the firm’s basal insulin analogue, Levemir (insulin detemir), in children aged two to five years with type 1 diabetes, making insulin detemir the only basal insulin analogue for use in this young patient group supported by its Summary of Product Characteristics (SmPC).

The extended license to market insulin detemir is based on a positive opinion granted in September by the European Committee for Medicinal Products for Human Use (CHMP) and data that demonstrate that insulin detemir is an equally efficacious treatment option for two to five-year-old children with type 1 diabetes, compared with NPH.

The pre-specified and stratified subgroup data show that children aged two to five years treated with insulin detemir plus a fast-acting insulin analogue, insulin aspart, experienced a lower rate of all-day and nocturnal hypoglycaemia compared to those taking human basal insulin (neutral protamine Hagedorn insulin) and insulin aspart (24-hour: 50.6 versus 78.3 episodes per patient year; nocturnal hypoglycemia: 8.0 versus 17.4 episodes per patient year).