Novo Nordisk Requests FDA Approval for Ultra-Long-Acting Insulin Degludec

Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus)

by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.

As with the European applications submitted on September 26, the U.S. filings are based on results from the BEGIN™ and BOOST™ clinical trial programs, which involved nearly 10,000 type 1 and type 2 diabetes patients. Data from the trials have shown insulin degludec to lower blood glucose levels, while demonstrating a low rate of hypoglycemia, especially at night. The trials also showed that insulin degludec can be administered once daily at any time of the day with the possibility to change injection time from day to day according to the needs of the individual patient.

Insulin degludec is an ultra-long-acting basal insulin analog discovered and developed by Novo Nordisk. It forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot from which there is a slow, continuous and extended release of insulin degludec. This may contribute to a lowering of blood glucose levels and low rates of hypoglycemia, especially at night.

Insulin degludec/insulin aspart contains the ultra-long-acting basal insulin degludec with a bolus boost of insulin aspart. Insulin degludec/insulin aspart is the first and only soluble insulin co-formulation of ultra-long-acting insulin degludec and insulin aspart providing both fasting and post-prandial control.

Novo Nordisk intends to make both insulins available in a prefilled delivery device. In the clinical trials, insulin degludec was studied in insulin pens that could either deliver up to 80 units or in a concentrated formulation up to 160 units in a single injection.