Novo Nordisk's diabetes drugs net EU clearance

The European Commission has granted marketing authorizations for insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg), both marketed by Novo Nordisk, for the treatment of diabetes in adults.

Tresiba is a once-daily new-generation basal insulin analogue, and Ryzodeg 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 Europe, Tresiba and Ryzodeg will be available in FlexTouch, Novo Nordisk's 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. 

Tresiba has been studied in the clinical trial program, BEGIN, examining its impact on glucose control, hypoglycemia and the possibility to flexibly adjust Tresiba dosing time to suit patient needs, according to the Bagsværd, Denmark-based Novo.

Tresiba and Ryzodeg were submitted to the European Medicines Agency and the FDA in September 2011 for regulatory review. In addition, applications have been submitted for regulatory approval in Japan, Canada, Switzerland and other countries. Tresiba and Ryzodeg were approved in Japan in September and December 2012, respectively. In November 2012, the products received a positive vote for approval from an FDA advisory panel.