Novo Nordisk files for EU approval of ultra-long-acting insulins Degludec and DegludecPlus

Danish insulin giant Novo Nordisk NVO: N) has made the first regulatory approval submissions, to the European Medicines Agency, for its ultra-long acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. This new generation of insulins has been developed for the treatment of people with type 1 and type 2 diabetes, the company pointed out.

“We believe that the ultra-long-acting insulin Degludec has the potential to make a significant difference in insulin therapy by offering lower rates of hypoglycemia and much greater flexibility than existing basal insulin,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, adding: “This is a significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin. Now, we are looking forward to making these new insulins available to diabetes patients as soon as possible after completion of the regulatory processes.”

To seek US clearance shortly