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FDA Approves Tresiba

FDA Approves Tresiba (insulin degludec) for Diabetes Mellitus

Bagsværd, Denmark, 25 September 2015 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Application (NDA).

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 (HbA1c), 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.

Novo Nordisk expects to launch Tresiba in 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.

On 26 March 2015, Novo Nordisk announced the decision to submit the class II resubmission of the NDA 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 (MACE) for the full trial analysis in mid-2016.

The FDA also approved Ryzodeg 70/30, the approved brand name for insulin degludec/insulin aspart, which 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 HbA1c.

"We are very happy with FDA's decision to approve Tresiba and Ryzodeg 70/30 as we believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes", said Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk. "The approvals mark an important milestone for Novo Nordisk and we look forward to making Tresiba available for people in the US".

Reflecting a separate action, Novo Nordisk today also announced that a New Drug Application for Xultophy, the first once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide), has been submitted to the FDA. The submission is expected to be reviewed under US FDA's Prescription Drug User Fee Act V (PDUFA V).

Source: Novo Nordisk

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