US FDA approves Tresiba and Ryzodeg

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba^® and Ryzodeg^® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs). 

Tresiba^®, the approved brand name for insulin degludec, is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. In 'treat-to-target' studies comparing Tresiba^® to insulin glargine, people using Tresiba^® achieved similar reduction in long-term blood glucose (HbA_1c), numerically greater fasting plasma glucose reduction, while using numerically lower doses of insulin in a majority of the studies. Furthermore, the studies demonstrated that Tresiba^® is the first basal insulin to offer people with diabetes the possibility of injecting their basal insulin at any time of the day with the option to adjust the time of injection. 

Ryzodeg^® 70/30, the approved brand name for insulin degludec/insulin aspart, contains insulin degludec in a soluble co-formulation with insulin aspart. Ryzodeg^® 70/30 can be administered once or twice daily with any main meal. In a 'treat-to-target' study supporting the new drug application where Ryzodeg^® 70/30 was compared to NovoLog^® Mix 70/30, Ryzodeg^® 70/30 showed equivalent reductions in HbA_1c.