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Antimicrobial Drugs Advisory Committee

On Tuesday, August 7, 2018, the Antimicrobial Drugs Advisory Committee (AMDAC) discussed a new drug application (NDA) for amikacin liposome inhalation suspension (ALIS), sponsored by Insmed, Inc. (Insmed), for the proposed indication of treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults, as part of a combination antibacterial drug regimen.

A majority of the Committee, 12 of 14 members, voted that Insmed has provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial lung disease caused by MAC, as part of a combination antibacterial drug regimen, for adult patients with limited or no treatment options. A same majority of the Committee, 12 of 14 members, did not support broader use for all adult patients with the disease.