US FDA accepts Tresiba® and Ryzodeg® resubmissions for review

Bagsværd, Denmark, 7 April 2015 - Novo Nordisk today announced that 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).

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. 

As previously communicated, the result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate derived from the interim analysis is thus only an indication of the final trial results.

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.

For further information

Company announcement No 26 / 2015