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# Insmed NDA for Rare Lung Disease
- URL: https://www.fdaweb.com/insmed-nda-for-rare-lung-disease/
- Published: 2018-05-16T12:00:00.000Z
- Updated: 2026-09-15T00:05:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141454

FDA has accepted for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex. The agency has granted a priority review and set a user (XXX SPELLING XXX)fee review action target of 9/28\. Insmed expects that FDA will convene an advisory committee meeting to discuss the submission.

NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. They also frequently require lengthy hospital stays to manage their condition.