Registered forecast
82% registered probability event by 2027-01-28 Unresolved
FDA approves the ARIKAYCE (amikacin liposome inhalation suspension) supplement extending the MAC lung disease indication beyond the refractory setting on or before the disclosed PDUFA goal date of 2027-01-28
FF-060 Registered - Registered probability
- 82%
- Decision by
- 2027-01-28
- Reading window
- 2026-11-08 → 2027-01-28
- Decision stage
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 80%
nextconsensus.com/forecast/ff-060/ registry snapshot 2026-11-07 Share image
NextConsensus registered this probability on 2026-11-04. It is one of 35 registered FDA goal-date forecasts.
The proposition
What was registered
The FDA takes an approval action on a supplement to NDA 207356 (ARIKAYCE, amikacin liposome inhalation suspension; applicant Insmed Inc) whose approved labeling extends the Mycobacterium avium complex (MAC) lung disease indication beyond adult patients with limited or no alternative treatment options in a refractory setting, with an approval action date on or before 2027-01-28, the PDUFA target action date disclosed in Exhibits 99.1 and 99.2 to Insmed’s Form 8-K filed 2026-10-29, for the sNDA that Exhibit 99.1 says FDA accepted with Priority Review in September 2026.
- Who decides
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Decision stageThe kind of body that has to act: a guideline panel, a regulator, or a payer. The ladder, rung by rung
- Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.
- Decision typeThe type of decision this forecast is counted with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Mycobacterium avium complex lung disease beyond the refractory setting
The estimate
The number and the baselines it has to beat
The estimate that the named body takes the action by the deadline, from what was public at the cutoff.
The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Efficacy supplements to an approved product, backed by a positive randomised phase 3 trial and under Priority Review, are approved at their first goal date more often than original applications. The calendar’s own met-goal-date share for disclosed PDUFA dates does not exist yet (docs/foundations/short-horizon-reference-classes.md §4.1).
A clock-only model: the goal date is inside the window, FDA meets most goal dates, and most first-cycle supplement actions are approvals. With no evidence input it cannot tell a strong application from a weak one.
An analyst reading the same filings on 2026-11-03 would weigh a randomised trial that met its primary and all controlled culture endpoints, Priority Review, and eight years of marketed use, against a narrow primary-endpoint margin on a patient-reported score and higher bronchospasm and discontinuation in an earlier-line population. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The method and every record are public, so you can check the work.
The clock
Dates that constrain the record
- Evidence as of
- 2026-11-07
Nothing after this date informed the estimate. - Registered
- 2026-11-04
Frozen and hashed. - Reading window
- 2026-11-08 → 2027-01-28
When the outcome can be read against the rule. - Event by
- 2027-01-28
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
a867e6e497eb1cc5c2718370544862b9ad8fab8ae48c3971452458630a0f8778 · operator record jc-1793799391475-79c72236 Around this record
- This kind of deadline
- Check it, follow it
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Name the asset, the deciding authority, and the date your team commits to: a P&T review, an HTA submission, a label negotiation, a deal closing, or a milestone dispute. Your stake need not be direct sponsorship — an asset you evaluate, finance, advise on, or rely upon is enough. Every commercial evaluation applies the same rigorous pre-registration and primary-source verification shown on this page, delivered privately under mutual NDA.
Resolution
The rule that settles the forecast
Resolves YES if the openFDA Drugs@FDA record for application NDA207356 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA207356%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-01-28, and the Drugs@FDA approval letter or the label approved with it states an INDICATIONS AND USAGE section for MAC lung disease, as part of a combination antibacterial drug regimen, that is no longer limited to patients with limited or no alternative treatment options in a refractory setting (for example, one that covers patients with a new occurrence of MAC lung infection, or adults with MAC lung disease without a refractory qualifier). The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 25, a labeling supplement approved 2026-06-25, and the indication was the 2018 accelerated-approval refractory indication (SRC-004, SRC-005). An approval that extends the indication to a narrower population than submitted still resolves YES, provided it reaches beyond the refractory setting. An approval that only converts the existing refractory indication to traditional approval, with no extension, resolves NO as partial_nonqualifying. Resolves NO if no qualifying approval action is dated on or before 2027-01-28: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and a qualifying approval dated after 2027-01-28 resolves NO as occurred_after_deadline. 2027-01-28 is a Thursday. Read no earlier than 2027-02-11; if openFDA has not refreshed, the Drugs@FDA web record for NDA207356 (https://www.accessdata.fda.gov/scripts/cder/daf/) governs. Resolves unresolvable only if neither source can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.
Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA207356%22, https://www.accessdata.fda.gov/scripts/cder/daf/
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 82% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-11-07.
- review pathway
- Priority review (SRC-001, SRC-002, SRC-004). Center CDER (NDA207356 listed in openFDA drugsfda, SRC-005).
- submission type
- Supplemental NDA (efficacy; new population) to NDA 207356, ARIKAYCE, which Insmed says also supports traditional approval of the existing refractory indication (SRC-002, SRC-003, SRC-005).
- evidence class
- One randomised, placebo-controlled phase 3b study, ENCORE (ARIKAYCE or placebo, each with azithromycin and ethambutol), in patients with a new occurrence of MAC lung infection who had not received antibiotics (SRC-003).
- pivotal n
- 425 (213 ARIKAYCE, 212 placebo) (SRC-003)
- endpoint type
- Patient-reported: change from baseline in Respiratory Symptom Score at month 13 (primary); culture conversion at months 6, 12 and 13 and durable conversion at month 15 (multiplicity-controlled secondary) (SRC-003).
- approved competitors in class
- ARIKAYCE is the only product the archived sources name as approved for MAC lung disease; the guideline regimen of azithromycin and ethambutol is its comparator background (SRC-003, SRC-004).
- months since last guideline revision
- not applicable — no guideline is the subject of this proposition
- panel cycle position
- not applicable — the act is an FDA approval action
- sponsor request status
- ENCORE topline 2026-03-23; sNDA accepted with Priority Review in September 2026, target action date 2027-01-28 (SRC-002, SRC-003, SRC-004). Latest approved supplement on NDA207356 at the cutoff: SUPPL 25, labeling, 2026-06-25 (SRC-005).
- odac referral
- none announced in the archived sources
- sponsor state change
- none bearing on the application recorded in the archived sources; Insmed reported ARIKAYCE worldwide revenue of USD 124.4 million for Q3 2026 (SRC-001).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-11-07 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
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SRC-001Insmed Form 8-K Exhibit 99.2, filed 2026-10-29: Q3 2026 results presentation. The ARIKAYCE slide reports Q3 2026 revenue (worldwide USD 124.4 million) and 'sNDA granted priority review by FDA, with PDUFA target action date of January 28, 2027', with an expected launch under an expanded all-MACLD label in the U.S. and Japan in 1H 2027 if approved. -
SRC-002Insmed Form 8-K Exhibit 99.1, filed 2026-10-29: Q3 2026 results release. In September 2026 FDA accepted Insmed's sNDA for ARIKAYCE for MAC lung disease as part of a combination antibacterial drug regimen, granted Priority Review and set a PDUFA target action date of January 28, 2027; ENCORE data to be submitted to Japan's PMDA in Q4 2026. -
SRC-003Insmed Form 8-K Exhibit 99.1, filed 2026-03-23: positive topline results from phase 3b ENCORE (ARIKAYCE or placebo, each with azithromycin and ethambutol, N=213 and 212) in patients with a new occurrence of MAC lung infection who had not received antibiotics. Primary endpoint, change in Respiratory Symptom Score at month 13, 3.11 points (p=0.0299); culture conversion at months 6, 12, 13 and durable at 15, differences 23.3 to 30.8 points (p<0.0001); PROMIS fatigue not significant. Bronchospasm 23.0% vs 11.8%; discontinuation 18.3% vs 11.8%. Insmed says the study was intended to fulfil the FDA post-marketing requirement and planned an sNDA for label expansion and traditional approval of the refractory indication. -
SRC-004Insmed Form 10-Q for the quarter ended 2026-09-30, filed 2026-10-29: ARIKAYCE received accelerated approval in September 2018 for MAC lung disease as part of a combination antibacterial drug regimen in adults with limited or no alternative treatment options in a refractory setting; in September 2026 the sNDA for patients with MAC lung disease was accepted with priority review, target action date January 28, 2027. -
SRC-005openFDA drugsfda application_number:"NDA207356", retrieved 2026-11-03: ARIKAYCE KIT, sponsor Insmed Inc; ORIG 1 approved 2018-09-28 (priority); SUPPL 3 efficacy 2020-10-19; latest approval SUPPL 25, labeling, 2026-06-25. No approval after 2026-06-25.