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FDA Accepts Novo Resubmission

The US Food and Drug Administration (FDA) has accepted for review Novo Nordisk’s 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, according to the company. 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.

The result of an interim analysis carries a higher level of uncertainty than the final study results because the preliminary estimate is built on a substantially lower number of observations, Novo Nordisk said.

Company 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