Novo Nordisk A/S (NVO) announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted positive opinions, recommending marketing authorisations, for Tresiba and Ryzodeg for the treatment of diabetes mellitus in adults.
Tresiba 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 HbA.
Ryzodeg contains the new-generation once-daily basal insulin degludec in a soluble formulation with insulin aspart. 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 HbA.
Novo Nordisk expects to receive final marketing authorisation from the European Commission within around two months. The company 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.
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