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FDA Approves Tresiba and Ryzodeg 70/30 for Diabetes
The FDA has approved insulin degludec (Tresiba, Novo Nordisk) and insulin degludec/insulin aspart (Ryzodeg 70/30, Novo Nordisk) for the treatment of diabetes mellitus in adults after reviewing the class II resubmissions of the new drug applications (NDAs), Novo Nordisk announced.
Tresiba 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 reductions in long-term blood glucose (HbA1c) and numerically greater fasting plasma glucose reduction, while using numerically lower doses of insulin in a majority of 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 contains insulin degludec in a soluble coformulation 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 NDA in which Ryzodeg 70/30 was compared to NovoLog Mix 70/30, Ryzodeg 70/30 showed equivalent reductions in HbA1c.
Novo Nordisk expects to launch Tresiba in the U.S. during the first quarter of 2016. Tresiba will be available in the FlexTouch device and will be offered in two concentrations, enabling maximum doses of 80 units and 160 units per injection, respectively.
On March 26, 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. 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 (MACE) for the full trial analysis in mid-2016.
In a separate action, Novo Nordisk announced that an NDA for Xultophy, the first once-daily single-injection combination of Tresiba and liraglutide (Victoza, Novo Nordisk), has been submitted to the FDA.
Source: Novo Nordisk; September 25, 2015.