Dupixent (dupilumab) label expanded: prurigo nodularis indication now includes adolescents aged 12–17
FDA approved a supplemental BLA expanding the dupilumab (Dupixent; Sanofi/Regeneron) indication for prurigo nodularis (PN) to include adolescents aged 12–17 years, in addition to the existing adult indication approved in 2022. Dupilumab is an IL-4Rα monoclonal antibody that blocks signalling from both IL-4 and IL-13 — cytokines central to Th2-driven inflammation and pruritus in PN. The adolescent approval was supported by the PRIME-PEDS phase 3 trial, demonstrating significant reduction in itch severity (WI-NRS) and skin lesion burden.
On 20 October 2026, FDA expanded the Dupixent (dupilumab) label to include prurigo nodularis (PN) in adolescents aged 12–17 years with moderate-to-severe disease. This follows the 2022 adult PN approval ↗. Dupilumab is a fully human monoclonal antibody targeting the shared receptor component for IL-4 and IL-13 (IL-4Rα).
About prurigo nodularis
Prurigo nodularis is a chronic neuro-inflammatory skin condition characterised by intensely pruritic hyperkeratotic nodules — typically on the extensor surfaces of the limbs and trunk. It is mediated by aberrant type 2 inflammation (IL-4, IL-13, IL-31, TSLP) and dysregulated sensory nerve signalling. Prevalence in the US is estimated at 72 per 100,000 adults; paediatric epidemiology is less well characterised. Patients experience significant sleep disruption, anxiety, and QoL impairment. Prior to dupilumab, management was largely off-label (topical corticosteroids, phototherapy, gabapentinoids). See the NIH/NCBI review of PN pathophysiology ↗.
Evidence: PRIME and PRIME2 programme
The adolescent expansion was supported by paediatric pharmacokinetic/pharmacodynamic bridging data from the adult PRIME (PN-1) and PRIME2 (PN-2) phase 3 trials, plus a dedicated adolescent cohort. In adults, dupilumab 300 mg Q2W achieved a ≥4-point reduction in itch NRS in ~60% of patients vs ~18% placebo at week 24 — PRIME results in NEJM ↗. The adolescent label carries the same dosing: 300 mg Q2W for patients ≥60 kg; weight-based dosing for those 30–<60 kg.
Prescribing context
Dupilumab is administered as a subcutaneous injection; adolescent patients (or carers) may self-inject after training. No mandatory REMS. Common adverse effects: conjunctivitis, injection-site reactions, and — at low frequency — facial/neck redness. The Dupixent full prescribing information ↗ and HCP site ↗ cover adolescent dosing tables. Report suspected adverse reactions to FDA MedWatch ↗. See our monoclonal antibody glossary entry for mechanism context.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.