The FDA refused to approve the ultra-long-acting insulin treatments 2 years ago.
Novo Nordisk will soon resubmit New Drug Applications (NDAs) for its ultra-long-acting insulin treatments that the FDA rejected 2 years ago.
Citing concerns about the type 2 diabetes drugs’ adverse cardiovascular effects, the FDA refused to approve insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg) in 2013, according to Bloomberg.
The FDA requested that Novo Nordisk conduct a clinical trial specifically comparing the cardiovascular safety of insulin degludec to that of insulin glargine in patients with type 2 diabetes at high risk of cardiovascular events.
Launched in October 2013, the randomized, double-blind, global DEVOTE trial is slated to study 7500 patients over a course of up to 5 years.
Although the trial isn’t expected to be completed until the second half of 2016, Novo Nordisk plans to submit an interim analysis of the DEVOTE data to the FDA seeking approval for insulin degludec. The company noted that its management does not have access to the results of the interim analysis, in order to preserve the integrity of the ongoing DEVOTE trial.
In its resubmission, Novo Nordisk will also include a safety update reflecting data from all clinical trials on insulin degludec, as well as post-marketing data. The company plans to resubmit NDAs for Tresiba and Ryzodeg within the next month.