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Home Industry News Novo Nordisk receives CHMP recommendation for expanded Levemir approval

Novo Nordisk receives CHMP recommendation for expanded Levemir approval

29th June 2015

Novo Nordisk has announced that its insulin detemir therapy Levemir has been recommended for EU approval in children with diabetes as young as one year old.

The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the expanded use of the drug in paediatric applications, based on positive findings from the BEGIN YOUNG 1 trial.

Results showed that Levemir, used once or twice daily in combination with insulin aspart, effectively improved long-term glycaemic control compared to baseline and was well-tolerated in children and adolescents with type 1 diabetes.

Novo Nordisk now expects to receive marketing authorisation from the European Commission within two to three months.

Jakob Riis, executive vice-president for Novo Nordisk, said: "We are pleased that once the European Commission approves this label expansion, there will be another basal insulin option for children as young as one in the EU."

Strong sales of its diabetes therapies were a key driver of growth for the company during the first quarter of 2015.ADNFCR-8000103-ID-801792624-ADNFCR

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