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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze