FDA committee votes in favour of Novo Nordisk's insulin products with post-approval trial


The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has completed its meeting regarding the NDA for Novo Nordisk's potential diabetes medications, insulin degludec and insulin degludec+insulin aspart.

At the meeting, the Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits and risks of the products, including a lower rate of hypoglycaemia and the potential cardiovascular (CV) risk profiles of the two products. The FDA asked the panel members to vote on whether a CV 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 CV outcomes trial should be conducted and voted eight to four in favour of approving the products with a post-approval outcomes trial commitment. 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 ultra-long duration of action 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, 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 post-prandial glucose control.

Insulin degludec and insulin degludec+insulin aspart were submitted to the EMA and FDA in September 2011 for regulatory review. The proposed tradenames for the two products are Tresiba and Ryzodeg, respectively. In addition, applications have been submitted for regulatory approval in Japan, Canada, Switzerland and a range of other countries. Tresiba was approved in Japan in September 2012, and in October, insulin degludec and insulin degludec+insulin aspart received positive CHMP opinions in Europe.