Arikayce (amikacin liposome inhalation suspension) for Mycobacterium avium complex (MAC) lung disease (full approval and label expansion)
The FDA is expected to decide on Arikayce for Mycobacterium avium complex (MAC) lung disease (full approval and label expansion) by January 28, 2027, under a sNDA from Insmed.
What is being decided
Insmed has a sNDA under FDA review for Arikayce (amikacin liposome inhalation suspension) in Mycobacterium avium complex (MAC) lung disease (full approval and label expansion). Priority review. Would convert the 2018 accelerated approval to full approval and expand use from refractory patients to those newly diagnosed with MAC lung disease, based on the Phase 3b ENCORE study, in which adding Arikayce to standard antibiotics raised culture conversion by month 6 to 88% from 57%.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Arikayce?
The FDA's target date (PDUFA date) for Arikayce in Mycobacterium avium complex (MAC) lung disease (full approval and label expansion) is January 28, 2027.
Who disclosed it: Insmed. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Insmed announcement
What is Arikayce being reviewed for?
Insmed submitted a sNDA for Arikayce in Mycobacterium avium complex (MAC) lung disease (full approval and label expansion).
What to know: Priority review. Would convert the 2018 accelerated approval to full approval and expand use from refractory patients to those newly diagnosed with MAC lung disease, based on the Phase 3b ENCORE study, in which adding Arikayce to standard antibiotics raised culture conversion by month 6 to 88% from 57%.
How much will Arikayce cost?
Insmed has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Arikayce decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Insmed announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.