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Novo Nordisk A/S Announces Tresiba and Ryzodeg Receive Marketing Authorizations in Europe


Monday, 21 Jan 2013 12:38pm EST 

Novo Nordisk A/S announced that the European Commission has granted marketing authorizations for Tresiba and Ryzodeg 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 analog 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 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 achieving equivalent reductions in HbA1c. In Europe, Tresiba and Ryzodeg will be available in FlexTouch, a prefilled insulin pen, which has an auto-injector mechanism. Tresiba will be offered in two concentrations enabling maximum doses of 80 and 160 units per injection, respectively.