US regulators have agreed to review Novo Nordisk’s resubmitted applications for diabetes drugs Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).
The Class II Resubmissions are based on interim analysis of data from the DEVOTE trial, which is looking at the cardiovascular effects of the long-acting insulins and is expected to complete in the second half of 2016.
In the meantime, to preserve the integrity of the trial, only a small team within the company has access to the data, Novo said.
While approved in Japan and Europe, Tresiba was rejected by the US Food and Drug Administration in February 2013 on heart safety concerns.
If the regulator is satisfied with the interim data provided in the resubmission, the drugs could be on the US market next year.