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Home Industry News Novo Nordisk’s Tresiba recommended for EU approval in children

Novo Nordisk’s Tresiba recommended for EU approval in children

22nd December 2014

Novo Nordisk has received a recommendation for EU approval of its diabetes therapy Tresiba in a new paediatric indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the approval of an expanded indication of Tresiba in children and adolescents with diabetes who are between the ages of one and 17.

Results from the Begin Young 1 study showed that once-daily Tresiba, in combination with insulin aspart, effectively improved long-term glycaemic control in paediatric patients, with a reduced risk of hyperglycaemia with ketosis versus insulin detemir.

Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, said: "When treating children and adolescents with diabetes, getting patients to target while minimising side effects is always a priority."

The drug was first approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes, either as a monotherapy or in combination with oral antidiabetic medicinal products or mealtime insulin.

It was then approved for combination use with GLP-1 receptor agonists in May 2014. A final decision on this new indication will be issued by the European Commission in the coming months.ADNFCR-8000103-ID-801767062-ADNFCR

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