FDA approves two new diabetes drug treatments

SILVER SPRINGS, Md. — The Food and Drug Administration on Friday approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar control in adults with diabetes mellitus. Both Tresiba and Ryzodeg are manufactured by Novo Nordisk.



"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,bdirector of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.



Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes mellitus, with dosing based on the patient’s needs. Tresiba is administered subcutaneously once daily. In clinical trial participants with Type 1 and Type 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c in line with reductions achieved with other 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. It is indicated to improve glycemic control in adults with diabetes mellitus. In clinical trial participants with Type 1 and Type 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 long-acting or pre-mixed insulin.



According to the FDA, Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine. The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.



According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes.