Press release
ARIKAYCE® (amikacin liposome inhalation suspension) Approved by Japan's Ministry of Health, Labour and Welfare for the Treatment of Patients with NTM Lung Disease Caused by MAC Who Did Not Sufficiently Respond to Prior Treatment with MDR
-- First and Only Therapy Approved in Japan, Europe, and United States for This Difficult-To-Treat Condition -- -- Product Launch Anticipated in Mid-2021 --
About this update from Insmed Incorporated
[{"type":"text","content":"-- First and Only Therapy Approved in Japan, Europe, and United States for This Difficult-To-Treat Condition --\n -- Product Launch Anticipated in Mid-2021 --\n\n\nBRIDGEWATER, N.J., March 23, 2021 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved ARIKAYCE® (amikacin liposome inhalation suspension) for the treatment of patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who did not sufficiently respond to prior treatment with a multidrug regimen (MDR). The launch of ARIKAYCE in Japan is anticipated in mid-2021.\n\"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,\" said Will Lewis, Chair and Chief Executive Officer of Insmed. \"We are excited by the opportunity to serve patients in Japan, where the burden of this disease is particularly high.\"\nThe approval by the MHLW is based on results from the randomized, open-label, global Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, when combined with MDR, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therapy alone. The most common side effects with ARIKAYCE affecting the respiratory system are dysphonia, cough, dyspnea, and hemoptysis. \n\"For many patients living with MAC lung disease, standard treatment is inadequate, leaving symptoms to potentially worsen over time,\" said Yuji Orihara, General Manager, Japan, Insmed. \"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.\" \nARIKAYCE is administered using the Lamira® Nebulizer System, which was authorized for use in Japan by the MHLW in June of 2020. As part of Insmed's comprehensive approach to patient care...