FDA Approves Diabetes Drugs

Ryzodeg 70/30 is a rapid-acting human insulin analog that can help treat adults with diabetes mellitus.

The U.S. Food and Drug Administration on Friday approved Danish drugmaker Novo Nordisk’s diabetes drug Tresiba, two years after rejecting the long-acting form of insulin.

Tresiba is a once-daily long-acting insulin analog indicated to improve glycemic control in adults with type 1 or type 2 diabetes.

Reflecting a separate action, Novo Nordisk today also announced that a New Drug Application for Xultophy, the first once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide), has been submitted to the FDA.

Accordingly, the company initiated a cardiovascular outcomes trial for Tresiba, dubbed DEVOTE, in October 2013, and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were accumulated by the end of January 2015.

“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, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.

Trials of almost 1,400 patients taking Ryzodeg 70/30 showed similar results. It is indicated to improve glycemic control in adults with diabetes mellitus.

Patients with raised ketone levels in their urine or blood shouldn’t take Ryzodeg and Tresiba, according to the FDA. As with all insulin regimens, patients and caregivers should carefully monitor blood glucose.

Insulin regimens should be modified cautiously and only under medical supervision. Both may cause hypoglycemia. As with any insulin, these treatments carry a risk of severe, life-threatening generalized allergy, as well. Treatment with Tresiba led to reductions in HbA1c in line with reductions achieved with other, previously approved long-acting insulin.