Registered forecast
88% registered probability event by 2027-02-23 Unresolved
FDA approves the ZORYVE (roflumilast) cream 0.05% supplement for atopic dermatitis in infants aged 3 to 24 months on or before the disclosed PDUFA goal date of 2027-02-23
FF-056 Registered - Registered probability
- 88%
- Event by
- 2027-02-23
- Resolution window
- 2026-10-27 → 2027-02-23
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 85%
- Calendar cycle 80%
- Analyst proxy 85%
nextconsensus.com/forecast/ff-056/ registry snapshot 2026-10-26 Share image
NextConsensus registered this probability on 2026-10-26. It is one of 28 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on a supplement to NDA 215985 (roflumilast, ZORYVE cream; applicant Arcutis Biotherapeutics) whose approved labeling extends ZORYVE cream 0.05% to the treatment of mild to moderate atopic dermatitis in infants younger than 2 years, with an approval action date on or before 2027-02-23, the PDUFA target action date disclosed in Arcutis’s Form 10-Q filed 2026-08-05.
- Authority
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. 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.
- Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Mild to moderate atopic dermatitis in infants 3 to 24 months
The estimate
The number and the baselines it has to beat
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 that extend an approved product to a younger pediatric age group 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 2026-10-21 would weigh the same strength already approved for children 2 to 5, a sponsor with seven approvals in four years on this product family, and low systemic exposure from a topical cream, against a small open-label four-week infant study as the only new efficacy and safety evidence. 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 clock
Dates that constrain the record
- Evidence cutoff
- 2026-10-26
Nothing after this date informed the estimate. - Registered
- 2026-10-26
Frozen and hashed. - Resolution window
- 2026-10-27 → 2027-02-23
When the outcome can be read against the rule. - Event by
- 2027-02-23
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
0da7134ee5a59e2e0876cd4738ad186afcae68e6496ab24c8363a8d5c09a7fd1 · operator record jc-1793055163874-36604cbd
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Resolves YES if the openFDA Drugs@FDA record for application NDA215985 (https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA215985%22) contains a submission with submission_type SUPPL, submission_status AP and a submission_status_date on or before 2027-02-23, and the Drugs@FDA approval letter or label for that supplement extends the ZORYVE cream 0.05% atopic dermatitis indication to patients younger than 2 years. The supplement is identified by that content, not by its number or class code. At the cutoff the latest approved supplement was SUPPL 15, approved 2026-06-29 (SRC-004), which is not this one: the 0.05% cream was then labeled for children 2 to 5 years old, and Arcutis described the infant supplement as under review after that date (SRC-001, SRC-002). An approval whose lower age bound is above 3 months but below 2 years still resolves YES. Resolves NO if no approval action is dated on or before 2027-02-23: 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 an approval dated after 2027-02-23 resolves NO as occurred_after_deadline. 2027-02-23 is a Tuesday. Read no earlier than 2027-03-09; if openFDA has not refreshed, the Drugs@FDA web record for NDA215985 (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:%22NDA215985%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
- 88% 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 2026-10-26, including the one field whose value was unknown then. It is left unknown rather than filled in.
- review pathway
- Standard review, inferred: the sNDA was submitted in the second quarter of 2026 (SRC-003 states the plan) and accepted in June 2026 with a goal date of 2027-02-23 (SRC-001, SRC-002); the archived sources do not name a designation. Center CDER (NDA listed in openFDA drugsfda, SRC-004).
- submission type
- Supplemental NDA (efficacy; new pediatric age group) to NDA 215985, ZORYVE cream 0.05% (SRC-001, SRC-002, SRC-004).
- evidence class
- One open-label, multicenter phase 2 study, INTEGUMENT-INFANT, once daily for four weeks, plus the earlier maximal-use pharmacokinetic trial ARQ-151-105 in the same age group (SRC-003).
- pivotal n
- 101 (SRC-003)
- endpoint type
- Safety and tolerability (primary, per SRC-003’s description of the study as evaluating safety and tolerability); efficacy reported as EASI-75 at week 4 (58%) (SRC-003).
- approved competitors in class
- unknown — the archived sources do not name the treatments approved for atopic dermatitis in infants younger than 2 years
- 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
- sNDA accepted for review in June 2026 with a PDUFA target action date of 2027-02-23 (SRC-001, SRC-002). The latest approval on the application, SUPPL 15 on 2026-06-29, extended ZORYVE cream 0.3% in plaque psoriasis to children down to age 2 (SRC-002, SRC-004).
- odac referral
- none announced in the archived sources
- sponsor state change
- none recorded in the archived sources since the sNDA was accepted; Arcutis raised its 2026 net product sales guidance (SRC-002).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-26 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-001Arcutis Form 10-Q for the quarter ended 2026-06-30, filed 2026-08-05: Arcutis submitted an sNDA based on INTEGUMENT-INFANT to extend ZORYVE cream 0.05% to infants with atopic dermatitis down to 3 months, assigned a PDUFA target action date of February 23, 2027; its launch table lists the 0.05% cream for U.S. infants 3 months to 2 years as sNDA accepted for review in June. ZORYVE cream 0.05% was approved and launched for children 2 to 5 years old in October 2025. -
SRC-002Arcutis Form 8-K Exhibit 99.1, filed 2026-08-05: Q2 2026 results release. FDA accepted the sNDA for ZORYVE cream 0.05% to include infants aged 3 to 24 months with mild to moderate atopic dermatitis, target action date February 23, 2027; FDA approved ZORYVE cream 0.3% for plaque psoriasis down to age 2 in June 2026, described as the seventh FDA approval in four years; 2026 net product sales guidance raised. -
SRC-003Arcutis Form 10-K for 2025, filed 2026-02-25: INTEGUMENT-INFANT was a phase 2, open-label, multicenter study of ZORYVE cream 0.05% once daily for four weeks in 101 infants aged 3 months to under 24 months with mild to moderate atopic dermatitis, building on the maximal-use pharmacokinetic trial ARQ-151-105; well tolerated, all reported events mild to moderate, 58% reached EASI-75 at week 4; the sNDA was planned for the second quarter of 2026. -
SRC-004openFDA drugsfda application_number:"NDA215985", retrieved 2026-10-21 (meta last_updated 2026-10-20): ZORYVE cream 0.3%, 0.15% and 0.05%, applicant Arcutis; ORIG-1 approved 2022-07-29 and efficacy supplements SUPPL 2 (2023-10-05), 7 (2024-07-09), 12 (2025-10-04) and 15 (2026-06-29) approved. No approval after 2026-06-29.