FDA Accepts Resubmitted Applications for Tresiba, Ryzodeg

The U.S. Food and Drug Administration (FDA) has accepted the class II resubmissions for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), according to a press release from Novo Nordisk.

On March 26, the company announced its decision to resubmit the prespecified interim analysis data of the DEVOTE trial — an ongoing cardiovascular (CV) outcomes trial — as part of the resubmissions of the new drug applications (NDAs) of Tresiba and Ryzodeg.

In addition to the data from the interim analysis of DEVOTE, the class II resubmission will include a safety update comprised of data from all clinical trials involving insulin degludec and an overview of postmarketing data.

There is a higher level of uncertainty with the interim analysis vs. the final study results because the preliminary estimate is based on considerably fewer observations and is therefore only an indication of the final trial data, according to the release.

DEVOTE was initiated in October 2013 and data for the interim analysis were accumulated by the end of January 2015. The trial is expected to be completed in the second half of 2016.