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Compliance Alert: Vyvgart Hytrulo (gMG)

Configure Methodology
75
Caution

Vyvgart Hytrulo (gMG) scores 75/100 (Caution) based on analysis of 60s promotional content. 2 enforcement patterns detected across Visual Distraction, Fair Balance — “Family & Social Scenes” identified at 39.9s, previously cited in Jardiance (x3), Contrave, Qulipta. FDA enforcement letter on file dated Jan 30, 2026. Weakest dimension: Fair Balance at 63/100.

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

Patterns Detected (2)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Family & Social Scenes
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
79
39.9s – 53.5s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
63
2.20:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
75
Master
79
Visual
30%
75
Efficacy
25%
63
Fair Balance
20%
85
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 28.0s – 46.8s (18.8s of 60.0s total — 31.3% of ad)
39.9s — Family Social
0s60s
!
FDA Enforcement Action on File
FDA Letter Jan 30, 2026 View PDF →

Visual Evidence (1 clip)

39.9s – 53.5s Family Social

Recommendations

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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