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Novo to Resubmit Drugs to FDA

Novo Nordisk has decided to resubmit the prespecified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications (NDAs) of Tresiba® and Ryzodeg® to the US Food and Drug Administration (FDA). The resubmission is expected to take place within the next month, according to the company.

 The cardiovascular outcomes trial for Tresiba® (insulin degludec), DEVOTE, began in October 2013 and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were collected by the end of January 2015.

 “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,” a Novo Nordisk statement said. “Accordingly, the relative risk estimate that has been derived from the interim analysis is only an indication of the final trial results.” 

 The Class II Resubmission will include the data from the interim analysis of DEVOTE and a safety update including data from all clinical trials with insulin degludec as well as an overview of postmarketing data.

 Within a month of the resubmission, the FDA is expected to communicate either its acceptance of the filing or issue an Incomplete Response Letter. 

 Source: Novo Nordisk

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