FDA approves Tresiba (insulin degludec injection) for Type 1 and 2 Diabetes- Novo Nordisk
The FDA approved the new drug application for Tresiba (insulin degludec injection), from Novo Nordisk, 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.
The approval is based on data from the BEGIN clinical trial programme and includes an interim analysis of DEVOTE, the cardiovascular outcomes trial for Tresiba. The BEGIN clinical trial programme includes nine randomised, 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 HbA1C reductions (noninferiority) to FDA-approved comparators. The most common side effect in BEGIN was hypoglycaemia.
Comment: Tresiba was intended to compete with Lantus (insulin glargine), the best seller from Sanofi. Tresiba has advantages over Lantus as it has a longer half life and less hypoglycaemia. In the meantime Sanofi has now US approval for Toujeo (basal insulin), a longer-acting successor to Lantus.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins