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FDA approved Tresiba (insulin degludec injection, Novo Nordisk) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection, Novo Nordisk) for the treatment of diabetes mellitus.
FDA has approved insulin degludec injection (Tresiba, Novo Nordisk) and insulin degludec/insulin aspart injection (Ryzodeg 70/30, Novo Nordisk) for the treatment of diabetes mellitus.
More than 29 million Americans are affected by diabetes, with type 2 diabetes accounting for 90% to 95% of all diabetes cases.
Tresiba is a once-daily, long-acting basal insulin indicated for use alone, or in combination with oral antidiabetic medications or bolus insulin to improve glycemic control in adults with type 1 and type 2 diabetes mellitus. Tresiba has a long duration of action, more than 42 hours, which allows patients to dose the medication at any time of the day. Tresiba is the first new basal insulin molecule to be approved by FDA in 10 years.
Ryzodeg 70/30 is a mixture of 70% insulin degludec, a long-acting insulin, and 30% insulin aspart, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.
"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 FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”
The safety and efficacy of Tresiba in combination with mealtime insulin in patient with type 1 diabetes were evaluated in two 26-week and one 52-week clinical trials involving 1,102 participants. In type 2 diabetes, Tresiba was evaluated in combination with mealtime insulin or as an adjunct to oral antidiabetic drugs in four 26-week and two 52-week clinical trials involving 2,702 participants.
The safety and efficacy of Ryzodeg 70/30 in combination with mealtime insulin in patient with type 1 diabetes were evaluated in one 26-week trial involving 362 participants and its safety and efficacy in patients with type 2 diabetes was assessed in four 26-week clinical trials involving 998 patients.
Results of the trials showed that Tresiba and Ryzodeg, given to patients who had inadequate blood sugar control at trial entry, reduced hemoglobin A1C (HbA1c) similarly to reductions achieved with previously approved long-acting insulins and long-acting or pre-mixed insulins, respectively.
Tresiba and Ryzodeg may cause hypoglycemia and should be closely monitored with changes to dosage, coadministration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal or hepatic impairment. These drugs should not be used in patients with diabetic ketoacidosis. Other common adverse reaction associated with both Tresiba and Ryzodeg include allergic reactions, injection-site reaction, itching, rash, edema, and weight gain.