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Compliance Alert: Vyvgart Hytrulo (CIDP)

Configure Methodology
61
Caution

Vyvgart Hytrulo (CIDP) scores 61/100 (Caution) based on analysis of 60s promotional content. 3 enforcement patterns detected across Visual Distraction, Efficacy — “Outdoor & Physical Activity” identified at 30.7s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Jan 30, 2026. Weakest dimension: Visual Distraction at 43/100.

Vyvgart Hytrulo (CIDP) | argenx | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (3)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Outdoor & Physical Activity
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
43
30.7s – 36.9s
36.9s – 45.3s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 21 CFR 202.1(e)(1)
Visual Distraction
Daily Activities
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
43
18.4s – 24.1s
24.2s – 30.6s
30.7s – 36.9s
36.9s – 45.3s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
62
6.0s – 18.4s
51.9s – 60.0s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
61
Master
43
Visual
30%
62
Efficacy
25%
68
Fair Balance
20%
85
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 20.2s – 45.3s (25.0s of 60.1s total — 41.7% of ad)
18.4s — Daily Activities
24.2s — Daily Activities
30.7s — Daily Activities+Vd Outdoor Physical
36.9s — Outdoor Physical+Vd Daily Activities
0s60s
!
FDA Enforcement Action on File
FDA Letter Jan 30, 2026 View PDF →

Visual Evidence (4 clips)

18.4s – 24.1s Daily Activities
24.2s – 30.6s Daily Activities
30.7s – 36.9s Daily Activities, Outdoor Physical
36.9s – 45.3s Outdoor Physical, Daily Activities

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (20s–45s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
high
Initiate PromoMats review: Verify all efficacy claims against current approved labeling. Visual representations should align with clinical trial results referenced in the PI.
high
Escalate to regulatory affairs: FDA enforcement letter on file (Jan 30, 2026). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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