Novo Nordisk’s diabetes treatments approved in EU

Hannah Blake

pharmaphorum

The European Commission has granted marketing authorisation for Novo Nordisk’s adult diabetes treatments Tresiba and Ryzodeg. The approval covers all 27 European Union member states.

Tresiba (insulin degludec) is a once-daily new-generation based insulin analogue with an ultra-long duration of action.

Ryzodeg (insulin degludec / insulin aspart) contains the new-generation once-daily basal insulin degludec in a soluble formulation with insulin aspart.

Both of these products will be available in Europe in the Danish pharmaceutical company’s latest prefilled insulin pen, FlexTouch, which has an easy auto-injector mechanism.

“These marketing authorisations constitute significant milestones for Novo Nordisk and the treatment of diabetes. We look forward to making Tresiba and Ryzodeg available to many people with diabetes in Europe.”

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Novo Nordisk aims to launch Tresiba in the UK and Denmark during the first half of 2013 and in other European markets throughout the rest of the year and 2014. The company expects to launch Ryzodeg approximately one year after Tresiba.

The company is still waiting to hear whether Tresiba and Ryzodeg have received approval from the US FDA, following a positive recommendation from the US FDA Advisory Committee in November 2012.