The U.S. FDA has informed Novo Nordisk that a three-month extension period was required in order to complete its regulatory review of the new drug applications (NDA) for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes.
During the review period the FDA has asked for further data clarification and analyses. In response, Novo Nordisk has submitted a substantial amount of additional data. Due to the size and timing of these submissions the FDA considers them as major amendments to the NDAs. The agency has not requested additional clinical trials.
Novo Nordisk submitted the NDAs to the FDA on 29 September 2011, and with the extension of the review the action date is now 29 October 2012.
Insulin degludec is a once-daily, ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile. It has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs.
Insulin degludec/insulin aspart contains the ultra-long-acting basal insulin degludec in a formulation with a bolus boost of insulin aspart. Insulin degludec/insulin aspart is the first and only soluble insulin combination of ultra-long-acting insulin degludec and the most prescribed rapid acting insulin, NovoRapid (NovoLogin the US) providing both fasting and post-prandial glucose control.
Insulin degludec and insulin degludec/insulin aspart were submitted to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011 for regulatory review. In addition, applications have been submitted for regulatory approval in Japan, Canada, Switzerland and a range of other countries.