FDA approves Ryzodeg (insulin degludec/insulin aspart injection) for treatment of diabetes mellitus- Novo Nordisk

The FDA has approved Ryzodeg 70/30 (insulin degludec/insulin aspart injection) from Novo Nordisk, to improve blood sugar (glucose) control in adults with diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analogue, and insulin aspart, a rapid-acting human insulin analogue. It is indicated to improve glycemic control in adults with diabetes mellitus.

The efficacy and safety of Ryzodeg 70/30 used in combination with mealtime insulin for the treatment of patients with type 1 diabetes were evaluated in a 26-week active controlled clinical trial involving 362 participants exposed to Ryzodeg 70/30. The efficacy and safety of Ryzodeg 70/30 administered once or twice daily for the treatment of patients with type 2 diabetes were evaluated in four active controlled 26-week clinical trials involving 998 participants exposed to Ryzodeg 70/30. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin treatments.