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Novo resubmits Tresiba application

Denmark’s Novo Nordisk has made what could turn out to be the drug group’s most important decision of the year.

Foto: Jens Lindhe

Novo Nordisk has decided to submit the prespecified interim analysis of its DEVOTE study as part of a Class II Resubmission of the New Drug Applications of Tresiba and Ryzodeg to the FDA, the company writes in a press release. The resubmission is expected to take place within the next month.

The cardiovascular outcomes trial for Tresiba, DEVOTE, was initiated in October 2013 and the required number of major adverse cardiovascular events for the prespecified interim analysis were accumulated by the end of January 2015. The small team of Novo employees with access to the DEVOTE data has therefore decided that the interim analysis merited resubmission.

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