Novo Nordisk receives marketing authorizations for diabetes drugs in Europe

Novo Nordisk, a healthcare company, has received marketing authorizations from the European Commission 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 analogue 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 lower risk of overall and nocturnal hypoglycaemia, while achieving equivalent reductions in HbA1c. With a duration of action beyond 42 hours, Tresiba offers patients the possibility of adjusting the time of injection, when needed, the company said.

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-totarget' study supporting the new drug application where Ryzodeg was compared to Novomix, Ryzodeg demonstrated a lower risk of overall and nocturnal hypoglycaemia while achieving equivalent reductions in HbA1c, the company added.

In Europe, Tresiba and Ryzodeg will be available in FlexTouch, Novo Nordisk's new 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.

"These marketing authorisations constitute significant milestones for Novo Nordisk and the treatment of diabetes," said Mads Thomsen, executive vice president and chief science officer of Novo Nordisk. "We look forward to making Tresiba and Ryzodeg available to many people with diabetes in Europe."

Novo Nordisk expects to launch Tresiba in the UK and Denmark during the first half of 2013 and in other European markets throughout the rest of 2013 and 2014. Ryzodeg is currently expected to be launched approximately one year after Tresiba.