Novo Nordisk today announced the submission to the U.S. Food and Drug Administration of two new drug applications for ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart. These insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.
“We are very excited about being able to file for the approval of insulin degludec and insulin degludec/insulin aspart now also in the US,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk. “This is another significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin injections.”
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. Read the full article