IQWiG finds no hint of added benefit in children and adolescents for Tresiba

2 June 2015

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether Danish diabetes care giant Novo Nordisk’s (NOV: N) Tresiba (insulin degludec), alone or in combination with other blood-glucose lowering drugs, offers an added benefit over the appropriate comparator therapy.

Tresiba has been approved since January 2015 for adolescents and children from the age of one year with type 1 or type 2 diabetes mellitus.

No added benefit of insulin degludec for adolescents and children with type1 diabetes mellitus can be derived from the dossier, stated the IQWiG. However, in girls there is a hint of greater harm regarding serious adverse events. Since the manufacturer presented no data for adolescents and children with type 2 diabetes, no conclusion on greater or lesser benefit can be drawn for this therapeutic indication. No advantages for children and adolescents with type 1 diabetes

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