Japan's MHLW clears Novo Nordisk's Levemir

Danish insulin giant Novo Nordisk says that the Japanese Ministry of Health, Labor and Welfare has approved Levemir (insulin detemir), its long-acting modern insulin for use in type 1 and type 2 diabetes, including combination treatment with oral anti-diabetics.

Novo Nordisk expects to launch the agent in Japan in its prefilled FlexPen device and in Penfill for its NovoPen injection systems before the end of the year. With the new approval, Novo Nordisk will be the only company in Japan offering rapid-acting, pre-mixed as well as long-acting modern insulins. Levemir is released gradually and entails less fluctuation in blood glucose levels and better predictability compared to traditional long-acting insulins.

According to the firm, diabetes currently affects more than 16 million people in Japan, while 7.4 million have diabetes or glucose levels indicating diabetes and 8.8 million have pre-diabetes. Levemir was approved in Europe in 2004 and in the USA in 2005, and is currently marketed in 58 countries worldwide. The firm noted that the approval of the agent in Japan does not change its financial results expectations for 2007.