By Fineline Cube 
AbbVie (NYSE: ABBV) announced it has submitted new indication applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) as a treatment for adult and adolescent patients with non‑segmental vitiligo (NSV). The JAK inhibitor, already approved across multiple immune‑mediated inflammatory diseases, would expand into dermatology’s largest unmet need indication if approved.
Regulatory Filing & Drug Profile
| Item | Detail |
|---|---|
| Company | AbbVie (NYSE: ABBV) |
| Drug | Rinvoq (upadacitinib) |
| Mechanism | JAK inhibitor |
| New Indication | Non‑segmental vitiligo (NSV) in adults and adolescents |
| Regulatory Filings | FDA and EMA |
| Previous Approvals | US (2019), China (2022) for atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, nr‑axSpA, giant cell arteritis |
| Ongoing Phase III | Alopecia areata, hidradenitis suppurativa, Takayasu’s arteritis, systemic lupus erythematosus, vitiligo |
Market Context & Strategic Outlook
- Vitiligo Market: Global vitiligo treatment market valued at $1.5 billion : in 2025, projected to exceed $3 billion : by 2030; NSV represents ~90% : of cases
- Unmet Need: No approved systemic therapies for vitiligo; topical corticosteroids and JAK inhibitors (ruxolitinib) offer limited efficacy; oral JAK inhibitor could transform treatment paradigm
- Competitive Landscape: Incyte’s ruxolitinib cream approved for vitiligo in US; Pfizer’s Cibinqo in Phase III; Rinvoq’s oral formulation offers convenience advantage
- Revenue Potential: Analysts project $500–800 million peak annual sales for vitiligo indication, adding to Rinvoq’s $10 billion+ global franchise
- Strategic Value: Third major dermatology indication following atopic dermatitis and hidradenitis suppurativa; reinforces JAK leadership in immune‑mediated diseases
- Next Steps: PDUFA date expected Q4 2026; EMA decision anticipated Q1 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, commercial expectations, and revenue projections for Rinvoq. Actual results may differ due to FDA/EMA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech