Long-Acting Insulin Degludec Approved in EU


January 22, 2013

The European Commission has granted marketing authorization to 2 new diabetes products, long-acting insulin degludec (Tresiba, Novo Nordisk) and a combination agent containing insulin degludec with insulin aspart (Ryzodeg, Novo Nordisk), the company has announced. The approvals cover all 27 European Union member states.

The advisory panel to the European Medicines Agency recommended approval of insulin degludec last October, and in November it was endorsed by a US Food and Drug Administration advisory panel, which voted 8 to 4 in favor of licensing the novel insulin for people with both type 1 and type 2 diabetes, with the stipulation that the company conduct a rigorous postmarketing study to evaluate cardiovascular safety.

Insulin degludec is a long-acting basal insulin that forms soluble multihexamers on subcutaneous injection. It has a half-life of 25 hours, which is twice as long as the half-life of currently available basal insulin products, with a 42-hour duration of effect. It was designed to meet the need for a flat, consistent basal insulin that provides steady coverage for more than 24 hours and from day to day for all patients, with the primary advantage being reduced hypoglycemia, particularly at night, the company says. In addition, because of its long half-life, the dosing regimen for allows for flexibility if a patient misses or delays a dose.

Novo Nordisk is also seeking approval of Ryzodeg, the combination product, in the United States.