Arikayce approved in Japan: the first treatment of non-tuberculous branches caused by MAC...

Insmed is a global biopharmaceutical company dedicated to changing the lives of patients with severe and rare diseases.

MAC lung disease is a chronic, debilitating lung disease that can significantly increase morbidity and mortality.

In the United States and the European Union, Arikayce was approved in September 2018 and October 2020, respectively, for the treatment of NTM lung infections.

Will Lewis, Chairman and CEO of Insmed, said: “Today’s approval of Arikayce is an important milestone for patients with refractory MAC lung disease in Japan who have not previously been approved for this severe and chronic lung disease.

This approval is based on data from the global phase III clinical study CONVERT.

Arikayce is a new, once-daily, amikacin preparation for inhalation.

Insmed’s advanced lung liposome technology uses charged neutral liposomes to deliver amikacin directly to the lungs, where the drug will be absorbed by NTM-infected lung macrophages.

Current international treatment guidelines recommend that Arikayce be used in combination with a multi-drug regimen (MDR) for patients with MAC lung disease who have failed standard therapies for at least 6 months.

Original source: 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

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