Insmed Incorporated
ARIKAYCE
Mycobacterium avium complex (MAC) lung infection
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on ARIKAYCE for Mycobacterium avium complex (MAC) lung infection is expected Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“The Company plans to file a supplemental new drug application for ARIKAYCE in patients with MAC lung disease in the second half of 2026 to support potential label expansion and to obtain traditional approval for the existing refractory indi”