Two long-acting insulins approved for diabetes mellitus

FDA has approved two long-acting insulins by Novo Nordisk for the treatment of adults with diabetes mellitus.

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“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.”

Tresiba

Insulin degludec injection (Tresiba) is a long-acting insulin analog that is indicated to improve glycemic control in adult patients with type 1 and 2 diabetes mellitus. Its safety and efficacy for use in combination with mealtime insulin in patients with type 1 diabetes were based on three clinical trials of 1,102 participants who received Tresiba. It was also evaluated in six clinical trials of 2,702 participants who received Tresiba for use in combination with mealtime insulin or as an adjunct to oral antidiabetic medications for the treatment of patients with type 2 diabetes.

“Patients treated with Tresiba achieved levels of glycemic control similar to those achieved with Lantus (insulin glargine 100 U/mL) and Levemir (insulin detemir) and achieved statistically significant improvements compared to sitagliptin,” according to Tresiba’s package insert.

Tresiba should be administered subcutaneously once daily and can be given at any time of the day. The long-acting insulin will be available in two concentrations, 100 units/mL (U-100) and 200 units/mL (U-200), and in a FlexTouch prefilled pen.

Ryzodeg 70/30

Insulin degludec/insulin aspart injection (Ryzodeg 70/30) is a combination for a long-acting and rapid-acting human insulin analog, which is indicated to improve glycemic control in adult patients with diabetes.

Its safety and efficacy for use in combination with mealtime insulin for the treatment of adults with type 2 diabetes were based on one clinical trial of 362 participants who received Ryzodeg. The drug combination was also evaluated in four clinical trials with 998 participants receiving Ryzodeg once or twice daily for the treatment of type 2 diabetes.

“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,” FDA noted.

The most common adverse events during the clinical trials of Tresiba and Ryzodeg were hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, edema, and weight gain.

Tresiba and Ryzodeg are contraindicated in individuals with diabetic ketoacidosis.