Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba (insulin degludec) for the treatment of diabetes in China. Tresiba is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
Tresiba provides significantly lower risk of overall, severe and nocturnal hypoglycaemia (low blood sugar) and comparable reductions of blood sugar levels vs insulin glargine U100 in people with diabetes. Studies have also shown that Tresiba provides significantly lower variability in blood sugar levels compared to insulin glargine U100 and U300.
“There are more adults with diabetes in China than anywhere in the world, and we are delighted that the CFDA’s approval brings the availability of Tresiba in China one step closer,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. “Tresiba gives physicians and people with diabetes a new treatment option that provides equivalent reductions in blood glucose levels and significantly lower risk of hypoglycaemia.”
In the multinational, double-blinded Tresiba cardiovascular outcomes trial, DEVOTE, reported earlier this year, Tresiba demonstrated cardiovascular safety and a reduced rate of severe and nocturnal severe hypoglycaemia by 40% and 53% respectively compared to insulin glargine U100 in people with type 2 diabetes. In the double-blinded SWITCH trials, Tresiba demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100 in the full treatment period in people with type 1 and type 2 diabetes.
China has over 100 million people living with diabetes, and the number is expected to grow to more than 150 million people by 2040. Tresiba is expected to launch in China in Q1 2018.