Novo Nordisk insulin degludec passes first regulatory hurdle in Japan
Danish insulin giant Novo Nordisk (NOV: N) revealed on Friday that its ultra-long-acting insulin degludec has passed the review by Japan’s Ministry of Health, Labor and Welfare (MHLW) advisory committee. The remaining step in the regulatory process will now be an official approval from the MHLW.
The First Committee on Drugs of Pharmaceutical Affairs serves as an advisory body to the MHLW, related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is a critical milestone in the Japanese review process prior to a marketing authorization from the MHLW, the Copenhagen-based company noted.
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