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Novo Nordisk Receive Positive Opinions from the European Regulatory Authorities

Published: Tuesday, October 23, 2012
Last Updated: Tuesday, October 23, 2012
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The Committee for Medicinal Products for Human Use adopted positive opinions, recommending marketing authorisations, for Tresiba® and 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.

“We are very happy about the positive opinions from the CHMP. This gives us confidence, that we soon can make Tresiba® and Ryzodeg® available to many people with diabetes in Europe,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Novo Nordisk expects to receive final marketing authorisation 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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