8 June 2012
FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes.
The FDA informed Novo Nordisk that a three-month extension was required in order to complete its review of the new drug applications (NDA) for the two insulins.
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.
About insulin degludec and insulin degludec/insulin aspart
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. Insulin degludec has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia 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® (NovoLog® in the US) providing both fasting and post-prandial glucose control.
Insulin degludec and insulin degludec/insulin aspart have been 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.
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,000 employees in 75 countries, and markets its products in more than 190 countries. Novo Nordisk's B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com.
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