Novo Nordisk receives CHMP backing for new indication for NovoRapid

Novo Nordisk has announced that NovoRapid, its insulin aspart therapy for diabetes treatment, has been recommended for EU approval in a new indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on extending the use of NovoRapid in the European Union for children with diabetes from as young as one year old.

This approval was based on positive results from the BEGIN YOUNG 1 and BOOST T1D paediatric trials, which showed that the therapy was able to help improve glycaemic control, as well as being well-tolerated in children and adolescents with type 1 diabetes.

A final regulatory decision from the European Commission is now expected within the next two months. If approved, it will fill a gap in the market for an approved fast-acting mealtime insulin for children with diabetes as young as one year old.

Professor Thomas Danne from Auf der Bult Children's Hospital in Hannover said: "Once the European Commission approves this label extension, clinicians may soon have access to a well-trusted mealtime insulin to help manage this patient group."

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