Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart.

At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits associated with a lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.

At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits associated with a lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.

The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favour of approving the products with a postapproval outcomes trial commitment.

“The positive vote from the Advisory Committee marks an important step towards making insulin degludec and insulin degludec/insulin aspart available to patients with diabetes in the US. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.

About insulin degludec and insulin degludec/insulin aspart

Insulin degludec is a once-daily new-generation basal insulin analogue, with an ultralong duration of action, 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 new-generation 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 insulin degludec and the most prescribed rapid-acting insulin, NovoRapid® (NovoLog® in the US), providing both fasting and postprandial 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. Insulin degludec was approved in Japan in September 2012, and in October 2012 insulin degludec and insulin degludec/insulin aspart received positive CHMP opinions in Europe.