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Long-Acting Insulins Approved by FDA

by U.S. Medicine

October 11, 2015

PLAINSBORO, NJ – Physicians treating diabetes patients have new weapons in their arsenal.

The Food and Drug Administration recently approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve glucose control in adults with diabetes mellitus.

Both drugs are manufactured by Novo Nordisk in Plainsboro, NJ.

“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 is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba, which is administered subcutaneously once daily at any time of day, should be individualized based on the patient’s needs, according to the FDA.

Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. 

The FDA warned that Tresiba and Ryzodeg should not be used in those who have diabetic ketoacidosis. It also cautioned that the drugs can cause potentially life-threatening hypoglycemia, adding, “Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”


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