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Novo Nordisk Plans to Resubmit Rejected Insulin Product to FDA
Novo Nordisk has announced that it plans to resubmit its ultra–long-acting insulin product Tresiba (insulin degludec) to the FDA within the next month.
The FDA had asked the company to conduct a dedicated cardiovascular outcomes trial (DEVOTE) after refusing to approve Tresiba in 2013 because of concern that it might be linked to higher rates of heart attacks or strokes. The DEVOTE study was initiated in October 2013, and the required number of major adverse cardiovascular events for a prespecified interim analysis were accumulated by the end of January 2015.
The results of an interim analysis carry a higher level of uncertainty than the final study results, as this preliminary estimate is based on a substantially lower number of observations, Novo said. Accordingly, the relative risk estimate that has been derived from the interim analysis is only an indication of the final trial results.
In addition to the data from the interim analysis of the DEVOTE trial, the class II resubmission for Tresiba will comprise a safety update, including data from all clinical trials with insulin degludec as well as an overview of postmarketing data.
Following Novo’s resubmission, the FDA is expected to communicate its acceptance of the filing or issue an “incomplete response letter.” This usually occurs within a month of resubmission.
Novo’s move positions the company to obtain FDA approval for Tresiba as soon as October or November, putting it on track to launch by early 2016, according to industry analysts.
Novo vies with Sanofi and Eli Lilly in supplying insulin products to diabetics.
Sources: Novo Nordisk; March 26, 2015; and Reuters; March 27, 2015.