EU approves Tresiba and Ryzodeg (Novo Nordisk) for Diabetes

Novo Nordisk has announced that the European Commission on 21 January 2013, 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, 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-totarget 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 which is the latest prefilled insulin pen from Novo Nordisk and which has an easy auto-injector mechanism.

Novo Nordisk expects to launch Tresiba in the UK 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.