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FDA Approves Ryzodeg 70/30

FDA Approves Ryzodeg 70/30 (insulin degludec/insulin aspart) for Diabetes Mellitus

Bagsværd, Denmark, 25 September 2015 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Ryzodeg 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).

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 HbA1c.

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 Tresiba, the approved brand name for insulin degludec, 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.

"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.

Source: Novo Nordisk

Posted: September 2015

Ryzodeg 70/30 (insulin degludec and insulin aspart) FDA Approval History

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