Novo Nordisk Files Insulin Drugs to Rival Sanofi’s Lantus in Europe
Novo Nordisk has filed two marketing authorisation applications for approval to the European Medical Agency for their ultra long-acting insulin Degludec and insulin combination analogue DegludecPlus.
The submissions are based on results from the BEGIN and BOOST clinical trial programmes which involved nearly 10,000 type 1 and type 2 diabetes patients. Data from the trials show Degludec effectively lowers blood glucose levels, “while consistently demonstrating a significantly lower rate of hypoglycaemia” relative to Sanofi’s Lantus (insulin glargine), especially during the night.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, commented that “Degludec has the potential to make a significant difference in insulin therapy by offering lower rates of hypoglycaemia and much greater flexibility than existing basal insulin”.
Thomsen added “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.”
Novo Nordisk say that the trials also showed that 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, without compromising glycaemic control or safety”.
Analysts believe Degludec represents a major challenge to Lantus, the biggest-selling insulin product in the world which brought in around $3.50 billion last year. Novo Nordisk added that it expects to file Degludec and DegludecPlus with the US Food and Drug Administration (FDA) within two weeks.