Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Tresiba® (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba® is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba® provides a long duration of action beyond 42 hours. While patients are encouraged to take their insulin at the same time each day, Tresiba® allows patients to dose at any time of the day.
"Since 1923, Novo Nordisk has been committed to advancing insulin therapy for patients with diabetes, and we are proud to bring forward the first new basal insulin molecule to be approved by the FDA in 10 years," said Jesper Høiland, president of Novo Nordisk in the U.S. and executive vice president of Novo Nordisk A/S. "Novo Nordisk is excited to launch Tresiba® in the United States in the first quarter of 2016."
The approval is based on data from the BEGIN® clinical trial program and includes an interim analysis of DEVOTE, the cardiovascular outcomes trial for Tresiba®. The BEGIN® clinical trial program includes nine randomized, controlled, treat-to-target, open-label trials in patients with type 1 and type 2 diabetes from over 40 countries. The FDA concluded based on the provided data that Tresiba® improves glycemic control, achieving comparable A1C reductions (noninferiority) to FDA-approved comparators. The most common side effect in BEGIN® was hypoglycemia.
Tresiba® will be available in the FlexTouch® pen, which has no push-button extension, and will be offered in two concentrations enabling maximum doses of 80 units and 160 units per single injection, respectively. Tresiba® also offers other patient benefits such as eight weeks of in-use time at room temperature.
"Managing blood sugar levels is a daily challenge for many people living with diabetes," said Chris Sorli, M.D., Chair, Department of Diabetes, Endocrinology and Metabolism, and Medical Director of Diabetes Services, Billings Clinic, Billings, MT. "This new treatment option will provide patients with a new way to help control their blood sugar."
"After seeing the impact Tresiba® has had on patients worldwide, we look forward to bringing it to those living with diabetes here in the U.S.," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk. "With its long-acting profile, Tresiba® offers a new treatment option for adults living with diabetes who require a basal insulin."