- Novo Nordisk's Tresiba (insulin degludec injection) has been approved in the U.S. and is the first new FDA-approved basal insulin molecule in 10 years.
- Tresiba is a once-daily, long-acting basal insulin indicated for use in adults with either type 1 or type 2 diabetes.
- Novo Nordisk has announced that Tresiba will launch in the first quarter of 2016.
After being rejected for approval by the FDA in February 2013 over CVD concerns, Tresiba has been approved based on the strength of a large portfolio of clinical efficacy and safety data. More than 2,700 patients were involved in 52-week active-controlled trials which included patients with type 1 and type 2 diabetes.
Overall, patients achieved comparable rates of HbA1C control as other approved, long-acting basal insulins. The main side effect was hypoglycemia. Tresiba will be offered in the FlexTouch Pen, with maximum doses of 80 units and 160 units per injection.
Per guidance from the FDA, Novo is continuing to conduct heart-safety studies in patients who are being treated with Tresiba. As part of its submission, Novo provided interim heart safety data to the FDA, which was deemed acceptable for approval. Tresiba is already approved and available in the E.U. and in Japan.
But the U.S. market approval is unequivocally positive news for Novo, which has been chasing another direct competitor for Sanofi's flagship Lantus for years. Combined with Eli Lilly's announcement earlier this year that the company would be delaying its own long-acting insulin, the Tresiba approval comes with the potential of billions in sales.