Novo Nordisk has filed applications for approval in Europe of its ultra long-acting insulin Degludec and insulin combination analogue DegludecPlus.
The submissions made to the European Medicines Agency 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.
Novo says the 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 some $3.50 billion last year. Novo added that it expects to file Degludec and DegludecPlus with the US Food and Drug Administration within two weeks.