The Japanese Ministry of Health, Labour and Welfare has approved Insmed’s Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have not been successfully treated with a multi-drug regimen, and the company says that it expects to launch Arikayce in Japan by mid-year. Insmed announced the submission of the NDA to the MHLW in March 2020.
Arikayce was approved in the US for the treatment of NTM lung infections caused by MAC in adult patients who have limited treatment options in September 2018 and in Europe in October 2020. Insmed notes that PARI’s Lamira nebulizer system, which is used for delivery of the inhalation suspension, was authorized for use by the MHLW in June 2020.
Insmed Chair and CEO Will Lewis commented, “Today’s approval of Arikayce is a significant milestone for patients with refractory MAC lung disease in Japan, who currently have no approved treatments available specifically for this serious and chronic pulmonary disease. It is also the realization of Insmed’s long-term commitment to building our business in Japan, and a meaningful step in our efforts to bring Arikayce to patients with refractory MAC lung disease around the world. We are excited by the opportunity to serve patients in Japan, where the burden of this disease is particularly high.”
Insmed General Manager, Japan, Yuji Orihara said, “For many patients living with MAC lung disease, standard treatment is inadequate, leaving symptoms to potentially worsen over time. The need for new and effective approaches is clear and we look forward to making Arikayce available for appropriate patients in Japan in the coming months.”
Read the Insmed press release.
