Insmed has announced its submission of a new drug application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have not responded to other therapies sufficiently. Arikayce was approved by the US FDA for the same indication in September 2018.
The company said that a separate medical device notification (JMDN) for the PARI Lamira nebulizer system for delivery of Arikayce will be submitted to the MHLW.
Insmed General Manager of Japan Yuji Orihara said, “The submission of our JNDA filing for Arikayce marks an important step in our journey to transform the way NTM lung disease caused by MAC is managed for patients in Japan. We look forward to continuing our work with the regulatory authorities during the review period.”
The company also said that all employees will now work remotely, including trainers who normally instruct patients on how to use Arikayce in person. Training will now be conducted remotely. No supply chain disruptions are anticipated, Insmed added; with enough Arikayce on hand for at least 7 months and production still underway, the company expects to be able to meet demand through 2022.
Insmed Chairman and CEO Will Lewis commented, “Patients suffering from refractory NTM lung disease are typically older individuals with underlying lung conditions, and are often treated by pulmonologists and infectious disease specialists. These treating physicians are on the front lines in addressing this global pandemic and must now, understandably, focus their attention on COVID-19. We are active participants in the social distancing policy and recommend its adoption by others to try to help slow the spread of this virus and alleviate the demands on the US hospital system. We are committed to the NTM community, and will continue to support them through these trying circumstances.”
Read the Insmed press release.
