The insulin-maker’s product is designed to be a once-daily basal insulin with an ultra-long duration of action for people with diabetes.
“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,” EVP & chief science officer Mads Krogsgaard Thomsen said in prepared remarks.
“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 a cardiovascular outcomes trial, Tresiba was safe among people at risk for adverse cardiovascular events and reduced the rate of severe hypoglycemia, during the day and at night, by 40% and 53% compared to insulin glargine U100 in people with Type II diabetes.
In the Switch trials, Tresiba had significantly lower rates of overall hypoglycemia compared to insulin glargine U100 in people with Type I and Type II diabetes.
Nordisk said it expects Tresiba to launch in China in the first quarter of 2018.