Aerocrine passes regulatory milestone in Japan

SOLNA, Sweden – Aerocrine AB (STO:AERO-B) said that the Japanese authority (PMDA) has approved its FeNO (fractional exhaled nitric oxide)-measuring device, NIOX MINO ? from 2008 as a tool for assessing patients with airway inflammation such as asthma.

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA), decided on 28 March 2013, after a thorough review, to grant the 2008 version of the NIOX MINO marketing approval in Japan. As Aerocrine introduced a new version in 2010 of NIOX MINO, the approval will have limited impact on the company’s sales in Japan in the near future.

"We look upon this approval as a positive regulatory milestone. We are very proud of being the first company to receive approval for the FeNO-method in Japan," said Tobias Bergenblad, Commercial Director Aerocrine for Asia.

Asthma is a fast growing health care problem, which is caused by a chronic inflammation in the airways. Between 100 and 150 million people around the globe suffer from asthma and this number is rising. World-wide, deaths from this condition have reached over 180,000 annually according to statistics from WHO. There are about 3 million asthmatics in Japan of whom 7% have severe and 30% have moderate asthma.