Novo Nordisk now ready to launch Tresiba in Japan, following pricing accord

Danish insulin giant Novo Nordisk (NOV: N) yesterday announced that it has received approval of the price of Tresiba (insulin degludec), the new once-daily basal insulin for the treatment of type 1 and type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labor and Welfare.

The price approval comes as good news for the company, which over the weekend suffered a blow for its long-acting insulin products when the Food and Drug Administration called for more data, possibly delaying approval for several years (The Pharma Letter February 11). The Japanese move allows Novo Nordisk to commercially launch in Japan shortly after Tresiba is officially posted on Japan’s National Health Insurance price list on February 22.

The global clinical program supporting the new drug application for Tresiba involved close to 10,000 people with type 1 or type 2 diabetes. In the “treat-to-target” studies, where Tresiba was compared to insulin glargine, Tresiba successfully achieved equivalent reductions in HbA1c and was associated with significantly lower risk of night-time hypoglycaemia.

In Japan, Tresiba will be available in FlexTouch, Novo Nordisk’s latest prefilled insulin pen with an easy push-button. Tresiba is also available in Penfill, designed to be used with Novo Nordisk’s insulin delivery systems.