Novo Nordisk has been granted European approval for its new insulin drug treatments Tresiba and Ryzodeg.
The Danish pharmaceutical announced yesterday that the European Commission has granted marketing authorisations for the new diabetic products across all 27 European Union member states.
Tresiba is a once-daily new-generation basal insulin analogue that has a duration of action beyond 42 hours, making it “the first basal insulin to offer patients the possibility of adjusting their time of injectio, when needed”.
The drug has been widely touted by analysts as a potential blockbuster that could rival Sanofi’s Lantus – the world’s biggest-selling insulin product.
Ryzodeg contains Tresida in a soluble formulation along with Novo’s NovoMix (insulin aspart) and can be administered once or twice a day with main meal(s).
EC approval of both drugs for the treatment of adult diabetes patients comes after studies concluded that they outperformed similar medicines already on the market.
Tresiba demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia compared with Lantus, while successfully achieving equivalent reductions in HbA1c. Ryzodeg showed the same results when compared with Novo Nordisk’s NovoMix.
Mads Krogsgaard Thomse, Novo’s chief scientific officer, said the approvals “constitute significant milestones” for the firm and the treatment of diabetes.
The company expects to launch Tresiba in the UK and Denmark during the first half of 2013, followed by other European markets throughout the rest of 2013 and next year. Ryzodeg is currently scheduled for an early 2014 launch.

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