FDA OKs Novo Nordisk’s Diabetes Drugs
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Tresiba and Ryzodeg 70/30 for treating 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 analog with a half-life of 25 hours and a duration of action of at least 42 hours. 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.
Novo Nordisk expects to launch Tresibain the US during the first quarter of 2016. Tresiba will be available in the FlexTouch device and be offered in two concentrations enabling maximum doses of 80 units and 160 units per injection, respectively.
In March 2015, Novo Nordisk announced the decision to submit the Class II resubmissions of the NDAs following the completion of the interim analysis of the cardiovascular outcomes trial for insulin degludec, DEVOTE. In order to preserve the integrity of the ongoing DEVOTE trial, only a small dedicated team within Novo Nordisk has access to the data. Novo Nordisk management does not have access to the results of the interim analysis. The trial is still expected to have accrued the prespecified number of major adverse cardiovascular events for the full trial analysis in mid-2016.
In other news, Novo Nordisk also submitted a NDA to the FDA fo Xultophy, an once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide).
Source: Novo Nordisk