FDA approves new diabetes treatments
Tresiba is a long-acting insulin degludec injection shown to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 combines insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog 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," Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”
The Centers for Disease Control and Prevention reports that approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of the long-term complications.
The most common side effects associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema and weight gain.