FDA Accepts Resubmission of Novo Nordisk’s Tresiba and Ryzodeg

Novo Nordisk reports the US Food and Drug Administration (FDA) has accepted for review the Class II resubmissions for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).

The cardiovascular outcomes trial for Tresiba (insulin degludec), DEVOTE, was initiated in October 2013 and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were accumulated by the end of January 2015. In addition to the data from the interim analysis of DEVOTE, the Class II Resubmission will comprise a safety update including data from all clinical trials with insulin degludec as well as an overview of postmarketing data.

To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review on matters related to the interim analysis. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.

Source: Novo Nordisk 

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