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.

"We are very excited about the result of the review of insulin degludec," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, adding: "This is a significant milestone towards what may be the first approval of insulin degludec, an insulin with potential to fulfil unmet medical needs for millions of people with diabetes who require insulin."