ABBV · News · 20260922N
Regulatory Approval Milestones
AbbVie Inc. · 2026-09-22 · Importance 38 · Surprise 60 · In source text
The European Commission approved RINVOQ (upadacitinib) for active polyarticular juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to, or are intolerant of, one or more DMARDs. The approval covers polyarticular rheumatoid factor-positive or negative and extended oligoarticular disease. It includes a weight-based 1 mg/mL oral solution and is based on the open-label Phase 1 SELECT-YOUTH study together with adult rheumatoid arthritis data. The decision expands RINVOQ to 11 approved indications in the European Union and broadens AbbVie's pediatric immunology market opportunity.
Key facts
- Rinvoq sales were expected to reach around $10.2 billion in 2026 according to one report mentioning the drug's role as a significant growth driver for AbbVie. source
- A new weight-dosed oral solution formulation of RINVOQ was approved for use in patients with polyarticular juvenile idiopathic arthritis. source
- The EC approval of RINVOQ for pJIA was based on the open-label Phase 1 SELECT-YOUTH study and data from adults with rheumatoid arthritis. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | Rinvoq sales were expected to reach around $10.2 billion in 2026 according to one report mentioning the drug's role as a significant… |
| revenue | positive | probable | — | A new weight-dosed oral solution formulation of RINVOQ was approved for use in patients with polyarticular juvenile idiopathic arthritis. |