Novo Nordisk has confirmed that it is planning to re-file New Drug Applications in the US for diabetes drugs Tresiba and Ryzodeg within the next month.
The Danish drugmaker said it has decided to submit interim analysis of data from the DEVOTE trial as part of a Class II Resubmission of the NDAs, rather than complete a full study.
Despite having bagged clearance in Japan and Europe, Tresiba was rejected by the US Food and Drug Administration in February 2013 on heart safety concerns, with the agency demanding a new trial looking at the cardiovascular effects of the long-acting insulin. The DEVOTE trial was launched the following November.
The move to submit interim data signifies the company’s confidence in the results, and means the drug could be on the US market next year.