BioCentury
ARTICLE | Clinical News

FDA panel backs Insmed lung infection compound in narrow population

August 10, 2018 6:12 AM UTC

FDA's Antimicrobial Drugs Advisory Committee voted that ALIS (amikacin liposome inhalation suspension) from Insmed Inc. (NASDAQ:INSM) is effective and safe in the treatment of non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).

The panel voted 12-2 that the treatment can be given as part of a combination antibacterial drug regimen in adults with limited or no treatment options. However, the committee voted 12-2 against the candidate's efficacy and safety to treat the indication in a broad population of adults with NTM lung disease caused by MAC...

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