The Food and Drug Administration (FDA) has approved Tresiba (insulin degludec injection; Novo Nordisk) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection; Novo Nordisk) to improve glycemic control in adults with type 1 and type 2 diabetes mellitus.
Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba should be individualized based on the patient’s needs. Tresiba is administered subcutaneously once daily at any time of day. The approval of Tresiba for patients with type 1 diabetes in combination with mealtime insulin is based on two 26-week and one 52-week active-controlled clinical trials of 1,102 patients, and as add-on to common background oral antidiabetic drugs in patients with type 2 diabetes in four 26-week and two 52-week active-controlled trials of 2,702 patients. Treatment with Tresiba led to reductions in HbA1c in line with reductions achieved with other, previously approved long-acting insulin.
Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. The approval of Rzyodeg for patients with type 1 diabetes in combination with mealtime insulin is based on one 26-week active controlled trial of 362 patients, and as once or twice-daily treatment in four 26-week clinical trials of 988 patients. Treatment with Rzyodeg provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin in patients with inadequate blood sugar control at trial entry.
“Long-acting insulins play an essential role in the treatment of patients with type 1 diabetes and in patients with type 2 diabetes with advanced disease,” said Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”
For more information call (888) 463-6332 or visit FDA.gov.