ARIKAYCE

Bridgewater, N.J. – September 21, 2026 -- The U.S. Food and Drug Administration has accepted Insmed Incorporated's supplemental New Drug Application (sNDA) for full approval of ARIKAYCE (amikacin liposome inhalation suspension) to treat Mycobacterium avium complex (MAC) lung disease, granting Priority Review with a PDUFA target action date of January 28, 2027.

FDA sets January 28, 2027 decision date under Priority Review

The Priority Review designation applies to therapies that could offer significant improvement in safety or efficacy for serious conditions. Insmed said full approval would allow ARIKAYCE, administered via PARI Pharma's Lamira Nebulizer System, to reach patients earlier in their disease course, including newly diagnosed cases and those with recurrent infections.