Novo Nordisk granted EU approval for combo diabetes treatment

Novo Nordisk has received approval to market its new combination type 2 diabetes treatment across Europe.

The European Commission has given the okay to Xultophy, a once-daily single injection combination of Tresiba and Victoza, also known by their chemical names insulin degludec and liraglutide respectively.

It has been indicated for the treatment of adults diagnosed with type 2 diabetes and is to be used in conjunction with glucose-lowering oral drugs or basal insulin. 

The Danish pharmaceutical giant noted that for patients receiving only basal insulin therapy, Xultophy has demonstrated a reduction of 1.9 percent in HbA1c glycated haemoglobin.

Novo now plans to resubmit Tresiba for approval by the US Food and Drug Administration in mid-2015, with the outcomes of the cardiovascular trials requested by the regulator progressing quicker than anticipated.

The company's chief scientific officer Mads Krogsgaard Thomsen said the treatment "represents a new paradigm with the potential to transform how type 2 diabetes is treated".

Xultophy was granted approval in Switzerland last week and Novo expects to launch in the first European Union nations in the first half of next year.