Novo Nordisk will be breathing a huge sigh of relief after US regulators finally opened the door to its re-filed diabetes drugs Tresiba and Ryzodeg.
Following class II resubmissions for both drugs based on interim cardiovascular outcomes data for Tresiba, the US Food and Drug Administration has approved their use as treatments for patients with type II diabetes.
Tresiba (insulin degludec) is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. According to Novo, it is the first basal insulin to offer patients the possibility of injecting at any time of the day with the option to adjust timings, and a US launch is scheduled for the first quarter of next year.
Sister product Ryzodeg 70/30 contains insulin degludec in a soluble co-formulation with insulin aspart, and can be administered once or twice daily with any main meal.
Despite having bagged clearance in Japan and Europe, Tresiba was rejected by the US Food and Drug Administration in February 2013 on heart safety concerns, with the agency demanding a new trial looking at the cardiovascular effects of the long-acting insulin.
The DEVOTE trial was launched the following November, and is expected to complete next year.
Meanwhile, Novo also announced that it has filed a New Drug Application in the US seeking approval for Xultophy, the first once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide).