Novo Nordisk
Two drugs that improve blood sugar control in patients with type 1 and type 2 diabetes have been given marketing authority in the United States.
The Food and Drug Administration (FDA) approved Novo Nordisk’s insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) on 25 September 2015.
The decision to approve insulin degludec injection follows the results of clinical trials involving 1,102 patients with type 1 diabetes and 2,702 patients with type 2 diabetes when the product was used in combination with mealtime insulin. The long-lasting insulin brought about a reduction in haemoglobin A1c or glycosylated haemoglobin in patients who had inadequate blood sugar control.
The decision to approve insulin degludec/insulin aspart injection, when used in conjunction with mealtime insulin, was based on the results of clinical trials involving 362 type 1 and 998 type 2 patients. The drug produced the same reduction in HbA1c levels achieved with other approved long-acting or pre-mixed insulin, the FDA said.
“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,” says Jean-Marc Guettier, director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research.
The European Medicines Agency gave both products a licence in January 2013.
