Novo Nordisk files Tresiba/Victoza combo IDegLira for EU approval

Danish insulin giant Novo Nordisk (NOV: N) said today (May 31) that it has submitted a marketing authorization application to the European Medicines Agency for the approval of IDegLira, the combination product of insulin degludec (Tresiba, the once-daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza, the once-daily human GLP-1 analogue. IDegLira has been developed for the treatment of people with type 2 diabetes.

The European Union filing of IDegLira is based on results from the DUALT clinical trial programs which involved around 2,000 people with type 2 diabetes, together with the extensive clinical data generated in the development programs of the individual components insulin degludec and liraglutide.

In the DUALT program people treated once-daily with IDegLira achieved an average HbA1c reduction of 1.9% in both trials. Among people treated with IDegLira, 81% of those previously treated with oral anti-diabetics and 60% of those previously treated with basal insulin achieved the ADA and the European Association for the Study of Diabetes (EASD) HbA1c treatment target of 7%. People treated with IDegLira experienced a low rate of hypoglycemia, which was comparable to that of Tresiba, and achieved a reduction in body weight.