Biopharmaceutical company Insmed Incorporated (Nasdaq: INSM) disclosed on Monday that the US Food and Drug Administration has accepted its supplemental New Drug Application for ARIKAYCE (amikacin liposome inhalation suspension) for the treatment of Mycobacterium avium complex lung disease as part of a combination antibacterial regimen. The FDA granted Priority Review and set a PDUFA target action date of 28 January 2027.

The application seeks full approval of ARIKAYCE, which received accelerated approval in 2018 for refractory MAC lung disease. It is supported by the Phase 3b ENCORE study, conducted to fulfil the post-marketing requirement associated with the accelerated approval.

ENCORE met its primary endpoint and multiplicity-controlled secondary culture conversion endpoints, with ARIKAYCE plus multidrug therapy producing statistically significant improvements in respiratory symptoms and culture conversion compared with multidrug therapy alone. The 425-patient study also showed earlier, greater and more durable culture conversion, with no new safety signals.

Insmed plans to review the ENCORE results with Japan's Pharmaceuticals and Medical Devices Agency in Q4 2026 to support a potential label expansion in Japan.