EU Panel Backs Novo Nordisk’s Tresiba

October 19, 2012

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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorizations, for Novo Nordisk’s new insulin Tresiba and insulin Ryzodeg for the treatment of diabetes mellitus in adults.

Tresiba , the intended brand name for insulin degludec, is a new generation of once-daily basal insulin. 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 intended 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 „treat-to-target? studies 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 and 160 units per injection, respectively.

Novo Nordisk expects to receive final marketing authorization from the European Commission within approximately two months. Subject to the Commission?s approval and completion of pricing and reimbursement discussions, Novo Nordisk expects to launch Tresiba in a number of European markets in the beginning of 2013. Ryzodeg is currently expected to be launched approximately one year after Tresiba, in the respective markets.

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