Insmed receives FDA priority review for ARIKAYCE
- Insmed (NASDAQ:INSM) received FDA Priority Review for a supplemental application seeking full approval of ARIKAYCE for MAC lung disease.
- The FDA set a PDUFA target action date of January 28, 2027.
- The application is supported by Phase 3b ENCORE trial data involving 425 treatment-naïve patients.
Insmed (NASDAQ:INSM) received FDA Priority Review for its supplemental New Drug Application seeking full approval of ARIKAYCE (amikacin liposome inhalation suspension) for treating Mycobacterium avium complex (MAC) lung disease.
The application seeks to expand ARIKAYCE use earlier in the disease course, including newly diagnosed and recurrent MAC lung infections, with the FDA setting a PDUFA target action date of January 28, 2027.
The sNDA is supported by results from the Phase 3b ENCORE study, a randomized, double-blind, placebo-controlled trial involving 425 treatment-naïve MAC lung disease patients, where ARIKAYCE plus multidrug therapy met its primary endpoint and secondary culture conversion measures.
ARIKAYCE received accelerated approval from the FDA in 2018 under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and the current filing is intended to address the related post-marketing requirement.
Insmed said it plans to discuss ENCORE trial data with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2026 for potential label expansion.
