Treatment of diabetes in adults: Tresiba and Ryzodeg approved in European Union
Novo Nordisk announced that the European Commission has granted marketing authorisations for Tresiba ( Insulin degludec ) and Ryzodeg ( Insulin degludec / Insulin aspart ) for the treatment of diabetes in adults.
The authorisations cover all 27 European Union member states.
Tresiba is a once-daily new-generation basal insulin analogue with an ultra-long duration of action. In treat-to-target studies supporting the new drug application where Tresiba was compared to Insulin glargine ( Lantus ), Insulin deglutec has demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c. Further, with a duration of action beyond 42 hours, Tresiba is the first basal insulin to offer patients the possibility of adjusting the time of injection, when needed.
insulin degludec/insulin aspart,
Ryzodeg contains the new generation once-daily basal Insulin degludec in a soluble formulation with Insulin aspart. Ryzodeg can be administered once or twice daily with the main meal(s). In a treat-totarget study supporting the new drug application where Ryzodeg was compared to NovoMix, Ryzodeg has demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia while successfully achieving equivalent reductions in HbA1c.
In Europe, Tresiba and Ryzodeg will be available in FlexTouch, Novo Nordisk’s latest prefilled Insulin pen, which has an easy auto-injector mechanism. Tresiba will be offered in two concentrations enabling maximum doses of 80 and 160 units per injection, respectively.
Source: Novo Nordisk, 2013
XagenaMedicine2013