The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) completed its meeting regarding the New Drug Applications (NDA) for Novo Nordisk’s insulin degludec (to be marketed under the name Tresiba) 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 hypoglycemia and the cardiovascular risk profiles of the two products.
The FDA asked the panel members to vote on whether a cardiovascular outcomes trial should be conducted and whether sufficient safety and efficacy data had been provided to support marketing of insulin degludec and insulin degludec/insulin aspart.
The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favor of approving the products with a post-approval outcomes trial commitment.
The positive vote from the Advisory Committee marks an important step towards making the two therapies available to patients with diabetes in the U.S.
The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.
Insulin degludec is a once-daily new-generation basal insulin analogue, with an ultralong duration of action, discovered and developed by Novo Nordisk. It has a distinct slow absorption which provides a flat and stable action profile. Insulin degludec has been studied in a large-scale clinical trial program, 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 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 U.S.), providing both fasting and postprandial glucose control.
Insulin degludec and insulin degludec/insulin aspart were submitted to the European Medicines Agency (EMA) and the U.S. 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.