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# Insmed NDA for Alis in Lung Disease
- URL: https://www.fdaweb.com/insmed-nda-for-alis-in-lung-disease/
- Published: 2018-03-29T12:00:00.000Z
- Updated: 2026-09-14T23:56:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141102

Insmed has submitted an NDA for Alis (amikacin liposome inhalation suspension), indicated for treating adult patients with nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex. The filing is supported by data from the company’s pivotal Phase 3 CONVERT study conducted in subjects with refractory NTM lung disease. The company expects a six-month priority review.

Alis is an inhaled, once-daily formulation of amikacin, which is an established drug for parenteral administration that has demonstrated activity against a variety of NTM. Insmed says the older formulation is “limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function associated with this systemic exposure.” The new formualtion uses the company’s pulmonary liposome technology that uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages where the NTM infection resides, it says.