Novo Nordisk's Ryzodeg passes regulatory hurdle in Japan; diabetes burden review

3 December 2012

Global insulin market leader Novo Nordisk (NOV: N) of Denmark revealed this morning that its Ryzodeg (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan’s Pharmaceutical Affairs. The remaining step in the regulatory process is an approval from the Ministry of Health, Labour and Welfare.

The First Committee on Drugs of Pharmaceutical Affairs serves as an advisory body to the Ministry in matters related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is an essential milestone in the Japanese review process prior to a marketing authorization from the Ministry. Novo Nordisk expects to receive marketing authorization from the Ministry within a few months.

Tresiba price negotiations still underway

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