The U.S. Food and Drug Administration (FDA) accepted Insmed’s supplemental New Drug Application (sNDA) for ARIKAYCE. The agency granted Priority Review for the drug’s use as a combination therapy for Mycobacterium avium complex (MAC) lung disease.
The FDA established a Prescription Drug User Fee Act (PDUFA) target action date of January 28, 2027. Positive data from the Phase 3b ENCORE study supports the potential label expansion.
The new indication would allow ARIKAYCE use earlier in the treatment course. This shift aims to significantly broaden the drug's addressable patient population.
Institutional investor Andra AP fonden increased its position in Insmed by 55.9% during the second quarter.