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Tresiba and Ryzodeg receive marketing authorizations in Europe

Wednesday, January 23, 2013

The European Commission has granted marketing authorizations for Novo Nordisk’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults.

The authorizations cover all 27 European Union member states. Tresiba, the brand name for insulin degludec, 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, Tresiba 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.

Ryzodeg, the brand name for insulin degludec/insulin aspart, 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-to-target study supporting the new drug application where Ryzodeg was compared to NovoMix, Ryzodeg 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 units and 160 units per injection, respectively.

Novo Nordisk expects to launch Tresiba in the U.K. and Denmark during the first half of 2013 and in other European markets throughout the rest of 2013 and 2014. Ryzodeg is currently expected to be launched approximately one year after Tresiba.

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