FDA Reviews Resubmissions for Novo Nordisk's Long-Acting Insulin

Although the FDA refused to approve Novo Nordisk’s ultra-long-acting insulin treatments 2 years ago, the agency is now reviewing resubmitted applications for insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg).

When it originally rejected Tresiba and Ryzodeg in 2013, the FDA cited concerns over the diabetes drugs’ cardiovascular safety, and then asked Novo Nordisk to conduct a clinical trial comparing the cardiovascular safety of insulin degludec to that of insulin glargine in patients with type 2 diabetes at high risk of cardiovascular events.

In October 2013, Novo Nordisk launched the DEVOTE trial to study potential adverse cardiovascular effects in 7500 patients through the second half of 2016. In the meantime, to expedite the regulatory process, the company included an interim analysis of the DEVOTE data in its Class II Resubmissions to the FDA last month.

Tresiba is a once-daily basal insulin with a duration of action beyond 42 hours. When combined with bolus insulin aspart (NovoLog), it has been shown to improve long-term glycemic control in children and adolescents with type 1 diabetes.

Ryzodeg administered twice daily has been shown to provide glycemic control with fewer injections than a basal-bolus regimen for patients with type 2 diabetes.